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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
2
Product Code
EZX
Mesh, Surgical, Metal
2
Product Code
MIB
Elastomer, Silicone Block
2
Product Code
MIC
Implant, Muscle, Pectoralis
2
Product Code
BTX
Board, Arm (With Cover), Sterile
1
Product Code
FTL
Mesh, Surgical, Polymeric
2
Product Code
K
24
1250
3DMax Light Mesh
2
Cleared 510(K)
K
23
2373
Progrip™ Self-Gripping Polypropylene Mesh
2
Cleared 510(K)
K
23
3402
Bard 3DMax Mesh
2
Cleared 510(K)
K
23
2924
T-Line® Hernia Mesh
2
Cleared 510(K)
K
23
0671
Pitch PaSoft Tissue Reinforcement Device
2
Cleared 510(K)
K
23
0227
T-Line Hernia Mesh
2
Cleared 510(K)
K
22
3218
Parietene Macroporous Mesh
2
Cleared 510(K)
K
22
1556
T-Line Hernia Mesh
2
Cleared 510(K)
K
22
0540
ProGrip Self-Gripping Polypropylene Mesh
2
Cleared 510(K)
K
22
0091
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
2
Cleared 510(K)
K
22
0586
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
2
Cleared 510(K)
K
21
1132
ARISTE AB Mesh
2
Cleared 510(K)
K
21
1563
Pitch-Patchs
2
Cleared 510(K)
K
20
0918
SurgiWrap FROST
2
Cleared 510(K)
K
20
1143
VICRYL Mesh
2
Cleared 510(K)
K
20
0818
3DMax MID Anatomical Mesh
2
Cleared 510(K)
K
19
2636
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
2
Cleared 510(K)
K
19
3144
T-Line Hernia Mesh
2
Cleared 510(K)
K
19
2389
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
2
Cleared 510(K)
K
19
2443
Dextile Anatomical Mesh
2
Cleared 510(K)
K
19
1373
VICRYL Mesh
2
Cleared 510(K)
K
19
2112
FlexBand Plus
2
Cleared 510(K)
K
19
1545
Exogenesis Hernia Mesh
2
Cleared 510(K)
K
18
2008
Phasix ST Mesh with Echo 2 Positioning System
2
Cleared 510(K)
K
18
1935
Endoform Reconstructive Template - Non Absorbable
2
Cleared 510(K)
K
18
2087
DynaMesh-POSTERIOR
2
Cleared 510(K)
K
18
1094
Polydioxanone Surgical Scaffold
2
Cleared 510(K)
K
18
1268
PROLENE (Polypropylene) 3D Patch
2
Cleared 510(K)
K
18
0910
ULTRAPRO Mesh and ULTRAPRO ADVANCED
2
Cleared 510(K)
K
18
0829
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
2
Cleared 510(K)
K
18
0122
TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
2
Cleared 510(K)
K
17
2636
VitaMESH Macroporous PP Surgical Mesh
2
Cleared 510(K)
K
18
0030
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
2
Cleared 510(K)
K
17
3796
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
2
Cleared 510(K)
K
17
2395
Duatene bilayer mesh
2
Cleared 510(K)
K
17
2089
PROLENE Soft Polypropylene Mesh
2
Cleared 510(K)
K
17
0134
Reperen Surgical Mesh
2
Cleared 510(K)
K
16
3212
Parietene DS Composite Mesh
2
Cleared 510(K)
K
16
3576
GORE SYNECOR Preperitoneal Biomaterial
2
Cleared 510(K)
K
17
0294
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval
2
Cleared 510(K)
K
16
3152
PROLENE Soft Polypropylene Mesh
2
Cleared 510(K)
K
16
1550
DynaMesh-VENTRAL
2
Cleared 510(K)
K
15
3632
Endoform Reconstructive Template
2
Cleared 510(K)
K
15
3236
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
2
Cleared 510(K)
K
15
2609
GORE SYNECOR Biomaterial
2
Cleared 510(K)
K
15
2678
TYRX Neuro Antibacterial Envelope
2
Cleared 510(K)
K
15
1386
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
2
Cleared 510(K)
K
14
3743
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
2
Cleared 510(K)
K
15
1437
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
2
Cleared 510(K)
K
15
0906
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
2
Cleared 510(K)
K
15
0091
Versatex Monofilament Mesh
2
Cleared 510(K)
K
14
2192
Insightra Freedom Ventral Hernia Repair System
2
Cleared 510(K)
K
15
0291
TYRX Neuro Absorbable Antibacterial Envelope
2
Cleared 510(K)
K
14
2706
Modified ONFLEX Mesh
2
Cleared 510(K)
K
14
2711
ONFLEX Mesh
2
Cleared 510(K)
K
14
3386
Progrip Laparoscopic Self-Fixating Mesh
2
Cleared 510(K)
K
14
2611
TYRX Neuro Absorbable Antibacterial Envelope
2
Cleared 510(K)
K
14
2908
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
2
Cleared 510(K)
K
14
2900
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
2
Cleared 510(K)
K
14
1560
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
2
Cleared 510(K)
K
14
2091
PARIETENE MACROPOROUS MESH
2
Cleared 510(K)
K
13
3889
PREMIUM
2
Cleared 510(K)
K
14
1394
X-REPAIR
2
Cleared 510(K)
K
14
1499
X-REPAIRSL
2
Cleared 510(K)
K
14
0967
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
2
Cleared 510(K)
K
13
3198
ULTRAPRO COMFORT PLUG
2
Cleared 510(K)
K
14
0941
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
2
Cleared 510(K)
K
13
2441
BARD VENTRALEX HERNIA PATCH
2
Cleared 510(K)
K
13
2699
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
2
Cleared 510(K)
K
13
0428
COVAMESH
2
Cleared 510(K)
K
13
1530
DYNAMESH -CICAT
2
Cleared 510(K)
K
13
1969
SYMBOTEX(TM) COMPOSITE MESH
2
Cleared 510(K)
K
13
1007
AIGIS RX N MEDIUM; AIGIS RX N LARGE
2
Cleared 510(K)
K
13
0943
AIGIS RX R PM/ AIGIS RX R ICD
2
Cleared 510(K)
K
13
0968
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
2
Cleared 510(K)
K
12
0844
MEDLINX SURGICAL MESH
2
Cleared 510(K)
K
12
3479
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
2
Cleared 510(K)
K
12
2436
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
2
Cleared 510(K)
K
11
3552
FREEDOM INGUINAL HERNIA IMPLANT
2
Cleared 510(K)
K
11
3229
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
2
Cleared 510(K)
K
11
3311
TIO2MESH TM
2
Cleared 510(K)
K
12
0897
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
2
Cleared 510(K)
K
12
0025
SURGIMESH XB - SKIRTED
2
Cleared 510(K)
K
12
0506
PARIETEX COMPOSITE VENTRAL PATCH
2
Cleared 510(K)
K
12
1070
C-QUR RPM MESH
2
Cleared 510(K)
K
11
1695
HYBRID GRAFT
2
Cleared 510(K)
K
11
1337
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
2
Cleared 510(K)
K
11
2567
BIOMERIX ASSURE
2
Cleared 510(K)
K
11
2499
BIOMERIX COMPOSITE SURGICAL MESH
2
Cleared 510(K)
K
11
2784
RENASYS AB ABOMINAL DRESSING KIT
2
Cleared 510(K)
K
11
0663
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
2
Cleared 510(K)
K
10
0313
HYDROFIX SURGICAL SHEET
2
Cleared 510(K)
K
11
1121
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
2
Cleared 510(K)
K
10
2788
TORNIER BIOFIBER SCAFFOLD
2
Cleared 510(K)
K
11
0816
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
2
Cleared 510(K)
K
11
0815
PARIETEX OPTIMIZED COMPOSTIE MESH
2
Cleared 510(K)
K
11
0820
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
2
Cleared 510(K)
K
10
1928
VENTRALEX ST HERNIA PATCH
2
Cleared 510(K)
K
10
1920
VENTRIO ST HERNIA PATCH
2
Cleared 510(K)
K
10
3682
PARIETEX PROGRIP
2
Cleared 510(K)
K
10
3445
ALACER SURGICAL SCAFFOLD
2
Cleared 510(K)
K
11
0110
ATRIUM CENTRILFX MESH
2
Cleared 510(K)
K
10
3568
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
2
Cleared 510(K)
K
10
2766
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
2
Cleared 510(K)
K
10
1519
PARIETEX PLUG AND PATCH
2
Cleared 510(K)
K
10
0787
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
2
Cleared 510(K)
K
10
1462
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
2
Cleared 510(K)
K
10
1851
VENTRALIGHT ST MESH
2
Cleared 510(K)
K
09
3196
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
2
Cleared 510(K)
K
09
2233
SURGIMESH XD
2
Cleared 510(K)
K
09
3123
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
2
Cleared 510(K)
K
10
1197
PARIE TENE PROGRIP MESH
2
Cleared 510(K)
K
09
3799
TORNIER SURGICAL MESH
2
Cleared 510(K)
K
10
0229
VENTRIO HERNIA PATCH
2
Cleared 510(K)
K
09
3932
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
2
Cleared 510(K)
K
09
3524
PIVIT A/B ST AND PIVIT A/B ST-R
2
Cleared 510(K)
K
09
2538
REFINE SUPPORT SYSTEM, MODEL 100.0100
2
Cleared 510(K)
K
10
0076
ATRIUM C-QUR OVT MESH
2
Cleared 510(K)
K
09
2224
TIGR SURGICAL MESH , MODEL WK-6
2
Cleared 510(K)
K
09
0271
HYDROCOAT MESH
2
Cleared 510(K)
K
09
2032
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
2
Cleared 510(K)
K
09
3166
WITTMANN PATCH
2
Cleared 510(K)
K
09
1659
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
2
Cleared 510(K)
K
09
0909
C-QUR V -PATCH MESH
2
Cleared 510(K)
K
09
0934
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
2
Cleared 510(K)
K
09
0489
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
2
Cleared 510(K)
K
08
3102
REFINE LIFT SYSTEM
2
Cleared 510(K)
K
09
0858
PARIETEX MONOFILAMENT POLYESTER MESH
2
Cleared 510(K)
K
09
0288
ORTHADAPT PR
2
Cleared 510(K)
K
08
3467
REBOUND HRDV
2
Cleared 510(K)
K
08
3307
SYNTHASOME X-REPAIR
2
Cleared 510(K)
K
08
3266
GORE BIO-A FISTULA PLUG
2
Cleared 510(K)
K
08
1377
NUVASIVE SURGICAL MESH SYSTEM
2
Cleared 510(K)
K
08
2748
ATRIUM PROLITE S MESH
2
Cleared 510(K)
K
08
2941
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
2
Cleared 510(K)
K
08
0442
SERISCAFFOLD SURGICAL MESH
2
Cleared 510(K)
K
08
1010
BARD 3DMAX MESH
2
Cleared 510(K)
K
08
1777
VENTRIO HERNIA PATCH
2
Cleared 510(K)
K
08
0216
SUPRAMESH EXTRA
2
Cleared 510(K)
K
08
2216
TBD ETHICON MESH
2
Cleared 510(K)
K
07
3579
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
2
Cleared 510(K)
K
07
2974
SURGIMESH XB
2
Cleared 510(K)
K
08
1126
PARIETEX COMPOSITE MONO PM MESH
2
Cleared 510(K)
K
07
2370
SURGICRAFT SURGICAL MESH SYSTEM
2
Cleared 510(K)
K
07
2962
CABS'AIR
2
Cleared 510(K)
K
08
1327
RELIMESH
2
Cleared 510(K)
K
08
1069
GORE INFINIT MESH
2
Cleared 510(K)
K
08
1050
PARIETEX PROGRIP MESH
2
Cleared 510(K)
K
08
0836
MODIFICATION TO ENDOFAST RELIANT SYSTEM
2
Cleared 510(K)
K
08
0691
C-QUR EDGE MESH V-PATCH
2
Cleared 510(K)
K
08
0688
C-QUR LITE MESH V-PATCH
2
Cleared 510(K)
K
08
0353
LTM-T SURGICAL MESH
2
Cleared 510(K)
K
08
0393
MODIFICATION TO REBOUND HRD
2
Cleared 510(K)
K
07
3287
PREVADH MESH
2
Cleared 510(K)
K
07
3164
IVS TUNNELLER DEVICES
2
Cleared 510(K)
K
07
0961
BIOMERIX SURGICAL MESH, MODEL: RCR-01
2
Cleared 510(K)
K
07
2190
ORTHO-WRAP BIORESORBABLE SHEET
2
Cleared 510(K)
K
06
3091
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
2
Cleared 510(K)
K
07
1695
KENSEY NASH MACROPORE SHIELD
2
Cleared 510(K)
K
07
2520
TEPHAFLEX SURGICAL FILM
2
Cleared 510(K)
K
07
1887
SPORTMESH OR ARTELON TISSUE REINFORCEMENT
2
Cleared 510(K)
K
07
1470
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
2
Cleared 510(K)
K
07
0918
4DDOME
2
Cleared 510(K)
K
06
3671
REBOUND HRD
2
Cleared 510(K)
K
07
0625
PELVIMESH / HERMESH 7
2
Cleared 510(K)
K
06
1934
XTAC
2
Cleared 510(K)
K
07
1629
PARIETEX POLYESTER MESH WITH INTRODUCER
2
Cleared 510(K)
K
06
3154
FACIAL RECONSTRUCTIVE MESH (FRM)
2
Cleared 510(K)
K
07
0846
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
2
Cleared 510(K)
K
07
1249
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
2
Cleared 510(K)
K
07
0993
TOPAS SYSTEM
2
Cleared 510(K)
K
07
0018
UNIVERSAL SURGICAL MESH, MODEL 100
2
Cleared 510(K)
K
07
0224
ULTRAPRO PLUG
2
Cleared 510(K)
K
07
0644
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
2
Cleared 510(K)
K
07
0192
ATRIUM PROLITE ULTRA S MESH
2
Cleared 510(K)
K
06
3648
SURGI-WRAP MAST TENDON SHEET
2
Cleared 510(K)
K
06
1445
SURGIMESH WN
2
Cleared 510(K)
K
06
3739
SEPRAMESH, MODEL 5959-1214
2
Cleared 510(K)
K
06
1533
PROCEED VENTRAL PATCH
2
Cleared 510(K)
K
06
3435
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
2
Cleared 510(K)
K
06
1754
BARD COMPOSITE L/P MESH
2
Cleared 510(K)
K
06
2697
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
2
Cleared 510(K)
K
06
1473
SURGI-WRAP MAST BIORESORBABLE SHEET
2
Cleared 510(K)
K
06
0329
ENDOFAST RELIANT SYSTEM
2
Cleared 510(K)
K
06
0018
TRULENE MESH
2
Cleared 510(K)
K
06
1704
OPTILENE MESH
2
Cleared 510(K)
K
05
3215
SURGICAL MESH SYSTEM
2
Cleared 510(K)
K
05
3656
TYRX ANTIMICROBIAL MESH
2
Cleared 510(K)
K
06
1314
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
2
Cleared 510(K)
K
06
0713
PROCEED SURGICAL MESH
2
Cleared 510(K)
K
05
0311
ATRIUM MEDICAL CORPORATION C-QUR MESH
2
Cleared 510(K)
K
06
0520
VITAMESH MACROPOROUS PP SURGICAL MESH
2
Cleared 510(K)
K
06
0004
CALDERA MESH
2
Cleared 510(K)
K
05
3424
POPMESH
2
Cleared 510(K)
K
05
2830
SPORTMESH
2
Cleared 510(K)
K
05
3158
OPTILENE MESH LP
2
Cleared 510(K)
K
05
2864
TYRX SURGICAL MESH, MODEL SMPC-0501
2
Cleared 510(K)
K
05
3066
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
2
Cleared 510(K)
K
05
3202
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
2
Cleared 510(K)
K
05
3200
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
2
Cleared 510(K)
K
05
2155
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
2
Cleared 510(K)
K
05
1701
VICRYL * MESH BAG
2
Cleared 510(K)
K
05
0969
INCLOSE SURGICAL MESH SYSTEM
2
Cleared 510(K)
K
05
2100
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
2
Cleared 510(K)
K
05
1766
ORTHOMEND
2
Cleared 510(K)
K
05
0332
SURGI-WRAP MAST BIORESORBABLE SHEET
2
Cleared 510(K)
K
05
0678
MOTIFMESH SOFT TISSUE PATCH
2
Cleared 510(K)
K
05
0418
TISSUE FIXATION SYSTEM
2
Cleared 510(K)
K
04
3191
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
2
Cleared 510(K)
K
05
0187
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
2
Cleared 510(K)
K
04
3081
GORE POLYPROPYLENE HERNIA MESH
2
Cleared 510(K)
K
04
3056
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
2
Cleared 510(K)
K
04
3366
PERMACOL SURGICAL IMPLANT
2
Cleared 510(K)
K
04
2811
VIVOSORB SHEET, MODEL FS01
2
Cleared 510(K)
K
04
2026
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
2
Cleared 510(K)
K
04
0998
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
2
Cleared 510(K)
K
03
3337
ULTRAPRO MESH
2
Cleared 510(K)
K
03
3814
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
2
Cleared 510(K)
K
03
3376
UGYTEX MESH
2
Cleared 510(K)
K
03
2893
SHELHIGH NO-REACT BIOCUFF
2
Cleared 510(K)
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
2
PMA Approval
K
03
2865
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
2
Cleared 510(K)
K
03
2673
IMMIX PLASTIFILM
2
Cleared 510(K)
K
03
1225
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
2
Cleared 510(K)
K
03
1955
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
2
Cleared 510(K)
K
03
1925
PROCEED TRILAMINATE SURGICAL MESH
2
Cleared 510(K)
K
03
2168
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
2
Cleared 510(K)
K
03
1188
ORTHOMEND
2
Cleared 510(K)
K
03
0631
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
2
Cleared 510(K)
K
02
4199
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
2
Cleared 510(K)
K
02
2011
V.A.C. ABDOMINAL DRESSING
2
Cleared 510(K)
K
02
4008
SMALL BARD VENTRALEX PATCH
2
Cleared 510(K)
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
2
PMA Approval
K
02
3328
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
2
Cleared 510(K)
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
2
PMA Approval
K
02
1835
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
2
Cleared 510(K)
K
02
2782
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
2
Cleared 510(K)
K
02
2350
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
2
Cleared 510(K)
K
02
1736
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
2
Cleared 510(K)
K
01
4183
AFB (ABSORBABLE FOAM BUTTRESS)
2
Cleared 510(K)
K
01
2025
MACROPORE SURGIWRAP (TS)
2
Cleared 510(K)
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
2
PMA Approval
K
01
0533
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
2
Cleared 510(K)
K
01
0722
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
2
Cleared 510(K)
P
99
0028
FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT
2
PMA Approval
K
01
0035
IVS TUNNELLER
2
Cleared 510(K)
K
01
0228
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
2
Cleared 510(K)
K
00
2699
PARIETEX COMPOSITE (PCO) MESH
2
Cleared 510(K)
K
00
3917
MODIFICATION TO FLUOROTEX II SURGICAL MESH
2
Cleared 510(K)
K
00
3906
MODIFICATION TO FLUROTEX SURGICAL MESH
2
Cleared 510(K)
K
00
3990
SOFRADIM PARIETEX SURGICAL MESHES
2
Cleared 510(K)
K
00
3323
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
2
Cleared 510(K)
K
00
2721
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
2
Cleared 510(K)
K
00
2672
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
2
Cleared 510(K)
K
00
2479
BIOMESH P1 AND BIOMESH PLUG AND PATCH
2
Cleared 510(K)
K
00
2684
COMPOSIX E/X MESH
2
Cleared 510(K)
K
00
2351
FLUOROTEX II SURGICAL MESH
2
Cleared 510(K)
K
00
2093
ATRIUM LITE MESH
2
Cleared 510(K)
K
00
2071
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
2
Cleared 510(K)
K
00
1122
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
2
Cleared 510(K)
K
00
0849
SOFTFORM FACIAL IMPLANT
2
Cleared 510(K)
K
99
4328
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
2
Cleared 510(K)
K
99
2556
PERMACOL
2
Cleared 510(K)
K
00
0185
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
2
Cleared 510(K)
K
99
2991
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
2
Cleared 510(K)
K
98
3753
STAR TEMPORARY WOUND COVER
2
Cleared 510(K)
K
99
2189
GORE-TEX DUALMESH BIOMATERIAL
2
Cleared 510(K)
K
99
1400
PARIETENE POLYPROPYLENE MESH
2
Cleared 510(K)
K
99
1637
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
2
Cleared 510(K)
K
99
0930
3D ANATOMICAL MESH
2
Cleared 510(K)
K
98
4220
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
2
Cleared 510(K)
K
98
2532
PARIETEX
2
Cleared 510(K)
K
98
4197
FLUOROTEX SURGICAL MESH
2
Cleared 510(K)
K
98
2575
MESH, SURGICAL, POLYMERIC
2
Cleared 510(K)
K
98
2475
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
2
Cleared 510(K)
K
98
1756
SHELHIGH NO-REACT PNEUMOPLEDGETS
2
Cleared 510(K)
K
97
4540
SIS HERNIA REPAIR DEVICE
2
Cleared 510(K)
K
97
3955
HERNIAMESH SURGICAL MESHES
2
Cleared 510(K)
K
98
0483
MENTOR SUSPEND SLING
2
Cleared 510(K)
K
98
1051
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
2
Cleared 510(K)
K
97
3462
SOFTFORM FACIAL IMPLANT
2
Cleared 510(K)
K
97
3082
VENTRAL WALL DEFECT REDUCTION SILO
2
Cleared 510(K)
K
97
2412
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
2
Cleared 510(K)
K
97
1745
BARD COMPOSITE PROSTHESIS
2
Cleared 510(K)
K
97
0561
GRAFT PATCH
2
Cleared 510(K)
K
97
1472
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
2
Cleared 510(K)
K
96
4857
RAPISEAL PATCH
2
Cleared 510(K)
K
96
5038
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
2
Cleared 510(K)
K
96
4761
S.A.M. FACIAL IMPLANT W/INTRODUCER
2
Cleared 510(K)
K
96
3226
SURGICAL FABRICS
2
Cleared 510(K)
K
96
3619
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
2
Cleared 510(K)
K
96
3141
KUGEL HERNIA PATCH
2
Cleared 510(K)
K
96
2971
POLYPROPYLENE MESH (VARIOUS SIZES)
2
Cleared 510(K)
K
96
2496
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
2
Cleared 510(K)
K
96
2401
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
2
Cleared 510(K)
K
96
2530
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
2
Cleared 510(K)
K
96
1440
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
2
Cleared 510(K)
K
96
0481
SOFT TISSUE AUGMENTATION TUBE
2
Cleared 510(K)
K
96
0219
PROLEX MESH
2
Cleared 510(K)
K
95
4665
GLYCAR STAPLE STRIPS
2
Cleared 510(K)
K
95
5494
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
2
Cleared 510(K)
K
95
2898
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
2
Cleared 510(K)
K
95
1700
GORE-TEX SOFT TISSUE PATCH
2
Cleared 510(K)
K
95
1675
GORE-TEX MYCROMESH BIOMATERIAL
2
Cleared 510(K)
K
95
1676
GORE-TEX DUALMESH BIOMATERIAL
2
Cleared 510(K)
K
95
3577
BARD VISILEX MESH 3 X 6
2
Cleared 510(K)
K
94
6106
GORE-TEX DUALMESH PLUS BIOMATERIAL
2
Cleared 510(K)
K
94
6107
GORE-TEX MYCROMESH PLUS BIOMATERIAL
2
Cleared 510(K)
K
94
5060
HERNIA MESH INTRODUCTION SYSTEM
2
Cleared 510(K)
K
94
5899
GORE-TEX(R) CURVED SURGICALMEMBRANE
2
Cleared 510(K)
K
94
2911
GLYCAR TISSUE REPAIR PATCH
2
Cleared 510(K)
K
94
5377
TRELEX NATURAL(R) MESH
2
Cleared 510(K)
K
94
4413
ACM PTFE SURGICAL MESH
2
Cleared 510(K)
K
92
2452
GORE-TEX SOFT TISSUE PATCH PLUS
2
Cleared 510(K)
K
94
1299
FLARED PATCH
2
Cleared 510(K)
K
94
2583
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
2
Cleared 510(K)
K
93
3827
BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
2
Cleared 510(K)
K
93
0822
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
2
Cleared 510(K)
K
93
1936
GIANTURCO-HELFRICH HERNIS MESH
2
Cleared 510(K)
K
93
0669
ATRIUM POLYPROPYLENE MESH
2
Cleared 510(K)
K
92
6478
GORE-TEK(R) SOFT TISSUE PATCH
2
Cleared 510(K)
K
93
1150
GORE-TEX MICRO MESH
2
Cleared 510(K)
K
92
6565
GORE-TEX(TM) DUAL MESH
2
Cleared 510(K)
K
92
5148
AUTO SUTURE SURGICAL MESH DEPLOYER
2
Cleared 510(K)
K
92
4749
TRELEX MESH
2
Cleared 510(K)
K
92
2916
BARD MARLEX MESH DART
2
Cleared 510(K)
K
91
5526
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
2
Cleared 510(K)
K
91
4449
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
2
Cleared 510(K)
K
90
5655
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
2
Cleared 510(K)
K
84
0172
VENTRAL WALL DEFECT REDUCT SILO
2
Cleared 510(K)
K
83
3764
STERILIZATION OF GORE-TEX SOFT TISSU
2
Cleared 510(K)
K
82
0193
GORE-TEX TISSUE REINFORCEMENT PATCH
2
Cleared 510(K)
K
81
0428
VICRYL
2
Cleared 510(K)
K
79
2281
USHER'S MARLEX TUBULAR MESH
2
Cleared 510(K)
FTM
Mesh, Surgical
2
Product Code
FTN
Plastic Surgery And Accessories Kit
1
Product Code
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
3
Product Code
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
3
Product Code
FWP
Prosthesis, Chin, Internal
2
Product Code
FYI
Appliance, Facial Fracture, External
1
Product Code
FZD
Prosthesis, Ear, Internal
2
Product Code
FZE
Prosthesis, Nose, Internal
2
Product Code
FZF
Splint, Extremity, Inflatable, External
1
Product Code
GBI
Material, External Aesthetic Restoration, Used With Adhesive
1
Product Code
GBJ
Prosthesis, Adhesive, External
1
Product Code
JCQ
Prosthesis, Esophagus
2
Product Code
KCZ
Prosthesis, Breast, External, Used With Adhesive
1
Product Code
KDA
Prosthesis, Ptfe/Carbon-Fiber
2
Product Code
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
2
Product Code
LZK
Implant, Malar
2
Product Code
MCA
Tape, Surgical, Internal
2
Product Code
MNF
Implant, Temporal
2
Product Code
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
1
Product Code
NOD
Board, Arm (With Cover), Non-Sterile
1
Product Code
NOJ
Prosthesis, Breast, External, No Adhesive
1
Product Code
NOK
Material, External Aesthetic Restoration, No Adhesive
1
Product Code
NWA
Prosthesis, Tracheal, Preformed/Molded
2
Product Code
NYT
Prosthesis, Tracheal, Expandable, Polymeric
2
Product Code
ODU
Facial Implant
2
Product Code
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OOD
Surgical Film
2
Product Code
OQL
Mesh, Surgical, Deployment Balloon
2
Product Code
ORQ
Mesh, Surgical, Deployer
2
Product Code
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
2
Product Code
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
2
Product Code
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
2
Product Code
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
2
Product Code
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
2
Product Code
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
2
Product Code
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
2
Product Code
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
2
Product Code
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
2
Product Code
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
2
Product Code
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
2
Product Code
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
2
Product Code
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
2
Product Code
OXL
Mesh, Surgical, Absorbable, Organ Support
2
Product Code
OXM
Mesh, Surgical, Absorbable, Fistula
2
Product Code
OXN
Mesh, Surgical, Collagen, Fistula
2
Product Code
PIJ
Collagen Surgical Mesh Containing Drugs
2
Product Code
PQN
Carbon Dioxide Gas Controlled Tissue Expander
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
SU
/
subpart-d—prosthetic-devices
/
FTL
/
K053202
View Source
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053202
510(k) Type
Special
Applicant
W.L. GORE & ASSOCIATES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/7/2005
Days to Decision
21 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
EZX
Mesh, Surgical, Metal
MIB
Elastomer, Silicone Block
MIC
Implant, Muscle, Pectoralis
BTX
Board, Arm (With Cover), Sterile
FTL
Mesh, Surgical, Polymeric
K
24
1250
3DMax Light Mesh
K
23
2373
Progrip™ Self-Gripping Polypropylene Mesh
K
23
3402
Bard 3DMax Mesh
K
23
2924
T-Line® Hernia Mesh
K
23
0671
Pitch PaSoft Tissue Reinforcement Device
K
23
0227
T-Line Hernia Mesh
K
22
3218
Parietene Macroporous Mesh
K
22
1556
T-Line Hernia Mesh
K
22
0540
ProGrip Self-Gripping Polypropylene Mesh
K
22
0091
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K
22
0586
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
K
21
1132
ARISTE AB Mesh
K
21
1563
Pitch-Patchs
K
20
0918
SurgiWrap FROST
K
20
1143
VICRYL Mesh
K
20
0818
3DMax MID Anatomical Mesh
K
19
2636
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
K
19
3144
T-Line Hernia Mesh
K
19
2389
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
K
19
2443
Dextile Anatomical Mesh
K
19
1373
VICRYL Mesh
K
19
2112
FlexBand Plus
K
19
1545
Exogenesis Hernia Mesh
K
18
2008
Phasix ST Mesh with Echo 2 Positioning System
K
18
1935
Endoform Reconstructive Template - Non Absorbable
K
18
2087
DynaMesh-POSTERIOR
K
18
1094
Polydioxanone Surgical Scaffold
K
18
1268
PROLENE (Polypropylene) 3D Patch
K
18
0910
ULTRAPRO Mesh and ULTRAPRO ADVANCED
K
18
0829
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
K
18
0122
TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
K
17
2636
VitaMESH Macroporous PP Surgical Mesh
K
18
0030
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
K
17
3796
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
K
17
2395
Duatene bilayer mesh
K
17
2089
PROLENE Soft Polypropylene Mesh
K
17
0134
Reperen Surgical Mesh
K
16
3212
Parietene DS Composite Mesh
K
16
3576
GORE SYNECOR Preperitoneal Biomaterial
K
17
0294
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval
K
16
3152
PROLENE Soft Polypropylene Mesh
K
16
1550
DynaMesh-VENTRAL
K
15
3632
Endoform Reconstructive Template
K
15
3236
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
K
15
2609
GORE SYNECOR Biomaterial
K
15
2678
TYRX Neuro Antibacterial Envelope
K
15
1386
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
K
14
3743
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K
15
1437
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
K
15
0906
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
K
15
0091
Versatex Monofilament Mesh
K
14
2192
Insightra Freedom Ventral Hernia Repair System
K
15
0291
TYRX Neuro Absorbable Antibacterial Envelope
K
14
2706
Modified ONFLEX Mesh
K
14
2711
ONFLEX Mesh
K
14
3386
Progrip Laparoscopic Self-Fixating Mesh
K
14
2611
TYRX Neuro Absorbable Antibacterial Envelope
K
14
2908
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
K
14
2900
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
K
14
1560
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K
14
2091
PARIETENE MACROPOROUS MESH
K
13
3889
PREMIUM
K
14
1394
X-REPAIR
K
14
1499
X-REPAIRSL
K
14
0967
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
K
13
3198
ULTRAPRO COMFORT PLUG
K
14
0941
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
K
13
2441
BARD VENTRALEX HERNIA PATCH
K
13
2699
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
K
13
0428
COVAMESH
K
13
1530
DYNAMESH -CICAT
K
13
1969
SYMBOTEX(TM) COMPOSITE MESH
K
13
1007
AIGIS RX N MEDIUM; AIGIS RX N LARGE
K
13
0943
AIGIS RX R PM/ AIGIS RX R ICD
K
13
0968
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K
12
0844
MEDLINX SURGICAL MESH
K
12
3479
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K
12
2436
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K
11
3552
FREEDOM INGUINAL HERNIA IMPLANT
K
11
3229
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
K
11
3311
TIO2MESH TM
K
12
0897
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K
12
0025
SURGIMESH XB - SKIRTED
K
12
0506
PARIETEX COMPOSITE VENTRAL PATCH
K
12
1070
C-QUR RPM MESH
K
11
1695
HYBRID GRAFT
K
11
1337
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
K
11
2567
BIOMERIX ASSURE
K
11
2499
BIOMERIX COMPOSITE SURGICAL MESH
K
11
2784
RENASYS AB ABOMINAL DRESSING KIT
K
11
0663
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
K
10
0313
HYDROFIX SURGICAL SHEET
K
11
1121
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
K
10
2788
TORNIER BIOFIBER SCAFFOLD
K
11
0816
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
K
11
0815
PARIETEX OPTIMIZED COMPOSTIE MESH
K
11
0820
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
K
10
1928
VENTRALEX ST HERNIA PATCH
K
10
1920
VENTRIO ST HERNIA PATCH
K
10
3682
PARIETEX PROGRIP
K
10
3445
ALACER SURGICAL SCAFFOLD
K
11
0110
ATRIUM CENTRILFX MESH
K
10
3568
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
K
10
2766
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
K
10
1519
PARIETEX PLUG AND PATCH
K
10
0787
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K
10
1462
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
K
10
1851
VENTRALIGHT ST MESH
K
09
3196
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
K
09
2233
SURGIMESH XD
K
09
3123
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
K
10
1197
PARIE TENE PROGRIP MESH
K
09
3799
TORNIER SURGICAL MESH
K
10
0229
VENTRIO HERNIA PATCH
K
09
3932
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
K
09
3524
PIVIT A/B ST AND PIVIT A/B ST-R
K
09
2538
REFINE SUPPORT SYSTEM, MODEL 100.0100
K
10
0076
ATRIUM C-QUR OVT MESH
K
09
2224
TIGR SURGICAL MESH , MODEL WK-6
K
09
0271
HYDROCOAT MESH
K
09
2032
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
K
09
3166
WITTMANN PATCH
K
09
1659
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K
09
0909
C-QUR V -PATCH MESH
K
09
0934
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K
09
0489
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
K
08
3102
REFINE LIFT SYSTEM
K
09
0858
PARIETEX MONOFILAMENT POLYESTER MESH
K
09
0288
ORTHADAPT PR
K
08
3467
REBOUND HRDV
K
08
3307
SYNTHASOME X-REPAIR
K
08
3266
GORE BIO-A FISTULA PLUG
K
08
1377
NUVASIVE SURGICAL MESH SYSTEM
K
08
2748
ATRIUM PROLITE S MESH
K
08
2941
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
K
08
0442
SERISCAFFOLD SURGICAL MESH
K
08
1010
BARD 3DMAX MESH
K
08
1777
VENTRIO HERNIA PATCH
K
08
0216
SUPRAMESH EXTRA
K
08
2216
TBD ETHICON MESH
K
07
3579
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
K
07
2974
SURGIMESH XB
K
08
1126
PARIETEX COMPOSITE MONO PM MESH
K
07
2370
SURGICRAFT SURGICAL MESH SYSTEM
K
07
2962
CABS'AIR
K
08
1327
RELIMESH
K
08
1069
GORE INFINIT MESH
K
08
1050
PARIETEX PROGRIP MESH
K
08
0836
MODIFICATION TO ENDOFAST RELIANT SYSTEM
K
08
0691
C-QUR EDGE MESH V-PATCH
K
08
0688
C-QUR LITE MESH V-PATCH
K
08
0353
LTM-T SURGICAL MESH
K
08
0393
MODIFICATION TO REBOUND HRD
K
07
3287
PREVADH MESH
K
07
3164
IVS TUNNELLER DEVICES
K
07
0961
BIOMERIX SURGICAL MESH, MODEL: RCR-01
K
07
2190
ORTHO-WRAP BIORESORBABLE SHEET
K
06
3091
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
K
07
1695
KENSEY NASH MACROPORE SHIELD
K
07
2520
TEPHAFLEX SURGICAL FILM
K
07
1887
SPORTMESH OR ARTELON TISSUE REINFORCEMENT
K
07
1470
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K
07
0918
4DDOME
K
06
3671
REBOUND HRD
K
07
0625
PELVIMESH / HERMESH 7
K
06
1934
XTAC
K
07
1629
PARIETEX POLYESTER MESH WITH INTRODUCER
K
06
3154
FACIAL RECONSTRUCTIVE MESH (FRM)
K
07
0846
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
K
07
1249
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
K
07
0993
TOPAS SYSTEM
K
07
0018
UNIVERSAL SURGICAL MESH, MODEL 100
K
07
0224
ULTRAPRO PLUG
K
07
0644
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K
07
0192
ATRIUM PROLITE ULTRA S MESH
K
06
3648
SURGI-WRAP MAST TENDON SHEET
K
06
1445
SURGIMESH WN
K
06
3739
SEPRAMESH, MODEL 5959-1214
K
06
1533
PROCEED VENTRAL PATCH
K
06
3435
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K
06
1754
BARD COMPOSITE L/P MESH
K
06
2697
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K
06
1473
SURGI-WRAP MAST BIORESORBABLE SHEET
K
06
0329
ENDOFAST RELIANT SYSTEM
K
06
0018
TRULENE MESH
K
06
1704
OPTILENE MESH
K
05
3215
SURGICAL MESH SYSTEM
K
05
3656
TYRX ANTIMICROBIAL MESH
K
06
1314
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
K
06
0713
PROCEED SURGICAL MESH
K
05
0311
ATRIUM MEDICAL CORPORATION C-QUR MESH
K
06
0520
VITAMESH MACROPOROUS PP SURGICAL MESH
K
06
0004
CALDERA MESH
K
05
3424
POPMESH
K
05
2830
SPORTMESH
K
05
3158
OPTILENE MESH LP
K
05
2864
TYRX SURGICAL MESH, MODEL SMPC-0501
K
05
3066
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
K
05
3202
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K
05
3200
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K
05
2155
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K
05
1701
VICRYL * MESH BAG
K
05
0969
INCLOSE SURGICAL MESH SYSTEM
K
05
2100
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
K
05
1766
ORTHOMEND
K
05
0332
SURGI-WRAP MAST BIORESORBABLE SHEET
K
05
0678
MOTIFMESH SOFT TISSUE PATCH
K
05
0418
TISSUE FIXATION SYSTEM
K
04
3191
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
K
05
0187
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K
04
3081
GORE POLYPROPYLENE HERNIA MESH
K
04
3056
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K
04
3366
PERMACOL SURGICAL IMPLANT
K
04
2811
VIVOSORB SHEET, MODEL FS01
K
04
2026
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K
04
0998
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
K
03
3337
ULTRAPRO MESH
K
03
3814
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K
03
3376
UGYTEX MESH
K
03
2893
SHELHIGH NO-REACT BIOCUFF
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
K
03
2865
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K
03
2673
IMMIX PLASTIFILM
K
03
1225
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
K
03
1955
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
K
03
1925
PROCEED TRILAMINATE SURGICAL MESH
K
03
2168
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K
03
1188
ORTHOMEND
K
03
0631
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
K
02
4199
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
K
02
2011
V.A.C. ABDOMINAL DRESSING
K
02
4008
SMALL BARD VENTRALEX PATCH
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
K
02
3328
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
K
02
1835
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
K
02
2782
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K
02
2350
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K
02
1736
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K
01
4183
AFB (ABSORBABLE FOAM BUTTRESS)
K
01
2025
MACROPORE SURGIWRAP (TS)
P
99
0028
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
K
01
0533
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
K
01
0722
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
P
99
0028
FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT
K
01
0035
IVS TUNNELLER
K
01
0228
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K
00
2699
PARIETEX COMPOSITE (PCO) MESH
K
00
3917
MODIFICATION TO FLUOROTEX II SURGICAL MESH
K
00
3906
MODIFICATION TO FLUROTEX SURGICAL MESH
K
00
3990
SOFRADIM PARIETEX SURGICAL MESHES
K
00
3323
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K
00
2721
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K
00
2672
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K
00
2479
BIOMESH P1 AND BIOMESH PLUG AND PATCH
K
00
2684
COMPOSIX E/X MESH
K
00
2351
FLUOROTEX II SURGICAL MESH
K
00
2093
ATRIUM LITE MESH
K
00
2071
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
K
00
1122
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K
00
0849
SOFTFORM FACIAL IMPLANT
K
99
4328
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
K
99
2556
PERMACOL
K
00
0185
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K
99
2991
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
K
98
3753
STAR TEMPORARY WOUND COVER
K
99
2189
GORE-TEX DUALMESH BIOMATERIAL
K
99
1400
PARIETENE POLYPROPYLENE MESH
K
99
1637
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
K
99
0930
3D ANATOMICAL MESH
K
98
4220
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K
98
2532
PARIETEX
K
98
4197
FLUOROTEX SURGICAL MESH
K
98
2575
MESH, SURGICAL, POLYMERIC
K
98
2475
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
K
98
1756
SHELHIGH NO-REACT PNEUMOPLEDGETS
K
97
4540
SIS HERNIA REPAIR DEVICE
K
97
3955
HERNIAMESH SURGICAL MESHES
K
98
0483
MENTOR SUSPEND SLING
K
98
1051
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K
97
3462
SOFTFORM FACIAL IMPLANT
K
97
3082
VENTRAL WALL DEFECT REDUCTION SILO
K
97
2412
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K
97
1745
BARD COMPOSITE PROSTHESIS
K
97
0561
GRAFT PATCH
K
97
1472
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
K
96
4857
RAPISEAL PATCH
K
96
5038
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
K
96
4761
S.A.M. FACIAL IMPLANT W/INTRODUCER
K
96
3226
SURGICAL FABRICS
K
96
3619
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
K
96
3141
KUGEL HERNIA PATCH
K
96
2971
POLYPROPYLENE MESH (VARIOUS SIZES)
K
96
2496
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
K
96
2401
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K
96
2530
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K
96
1440
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
K
96
0481
SOFT TISSUE AUGMENTATION TUBE
K
96
0219
PROLEX MESH
K
95
4665
GLYCAR STAPLE STRIPS
K
95
5494
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
K
95
2898
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
K
95
1700
GORE-TEX SOFT TISSUE PATCH
K
95
1675
GORE-TEX MYCROMESH BIOMATERIAL
K
95
1676
GORE-TEX DUALMESH BIOMATERIAL
K
95
3577
BARD VISILEX MESH 3 X 6
K
94
6106
GORE-TEX DUALMESH PLUS BIOMATERIAL
K
94
6107
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K
94
5060
HERNIA MESH INTRODUCTION SYSTEM
K
94
5899
GORE-TEX(R) CURVED SURGICALMEMBRANE
K
94
2911
GLYCAR TISSUE REPAIR PATCH
K
94
5377
TRELEX NATURAL(R) MESH
K
94
4413
ACM PTFE SURGICAL MESH
K
92
2452
GORE-TEX SOFT TISSUE PATCH PLUS
K
94
1299
FLARED PATCH
K
94
2583
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
K
93
3827
BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
K
93
0822
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
K
93
1936
GIANTURCO-HELFRICH HERNIS MESH
K
93
0669
ATRIUM POLYPROPYLENE MESH
K
92
6478
GORE-TEK(R) SOFT TISSUE PATCH
K
93
1150
GORE-TEX MICRO MESH
K
92
6565
GORE-TEX(TM) DUAL MESH
K
92
5148
AUTO SUTURE SURGICAL MESH DEPLOYER
K
92
4749
TRELEX MESH
K
92
2916
BARD MARLEX MESH DART
K
91
5526
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
K
91
4449
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
K
90
5655
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
K
84
0172
VENTRAL WALL DEFECT REDUCT SILO
K
83
3764
STERILIZATION OF GORE-TEX SOFT TISSU
K
82
0193
GORE-TEX TISSUE REINFORCEMENT PATCH
K
81
0428
VICRYL
K
79
2281
USHER'S MARLEX TUBULAR MESH
FTM
Mesh, Surgical
FTN
Plastic Surgery And Accessories Kit
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
FWP
Prosthesis, Chin, Internal
FYI
Appliance, Facial Fracture, External
FZD
Prosthesis, Ear, Internal
FZE
Prosthesis, Nose, Internal
FZF
Splint, Extremity, Inflatable, External
GBI
Material, External Aesthetic Restoration, Used With Adhesive
GBJ
Prosthesis, Adhesive, External
JCQ
Prosthesis, Esophagus
KCZ
Prosthesis, Breast, External, Used With Adhesive
KDA
Prosthesis, Ptfe/Carbon-Fiber
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
LZK
Implant, Malar
MCA
Tape, Surgical, Internal
MNF
Implant, Temporal
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
NOD
Board, Arm (With Cover), Non-Sterile
NOJ
Prosthesis, Breast, External, No Adhesive
NOK
Material, External Aesthetic Restoration, No Adhesive
NWA
Prosthesis, Tracheal, Preformed/Molded
NYT
Prosthesis, Tracheal, Expandable, Polymeric
ODU
Facial Implant
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
OOD
Surgical Film
OQL
Mesh, Surgical, Deployment Balloon
ORQ
Mesh, Surgical, Deployer
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
OXL
Mesh, Surgical, Absorbable, Organ Support
OXM
Mesh, Surgical, Absorbable, Fistula
OXN
Mesh, Surgical, Collagen, Fistula
PIJ
Collagen Surgical Mesh Containing Drugs
PQN
Carbon Dioxide Gas Controlled Tissue Expander
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-d—prosthetic-devices
/
FTL
/
K053202
View Source
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053202
510(k) Type
Special
Applicant
W.L. GORE & ASSOCIATES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/7/2005
Days to Decision
21 days
Submission Type
Summary