FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
EPF
Hearing Aid, Group And Auditory Trainer
2
Product Code
NEA
Cement, Ear, Nose And Throat
2
Product Code
ESD
Hearing Aid, Air Conduction
1
Product Code
ESE
Larynx, Artificial (Battery-Powered)
1
Product Code
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
2
Product Code
ESX
Tack, Sacculotomy (Cody Tack)
2
Product Code
ESZ
Tube, Shunt, Endolymphatic
2
Product Code
ETA
Replacement, Ossicular Prosthesis, Total
2
Product Code
ETB
Prosthesis, Partial Ossicular Replacement
2
Product Code
K
13
0512
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
2
Cleared 510(K)
K
11
2616
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
2
Cleared 510(K)
K
08
0070
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
2
Cleared 510(K)
K
06
3374
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
2
Cleared 510(K)
K
06
1853
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
2
Cleared 510(K)
K
06
0518
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
2
Cleared 510(K)
K
03
3554
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
2
Cleared 510(K)
K
02
1479
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
2
Cleared 510(K)
K
01
3573
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
2
Cleared 510(K)
K
01
0442
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
2
Cleared 510(K)
K
00
3214
SMITH & NEPHEW PISTONS
2
Cleared 510(K)
K
00
2737
SMITH & NEPHEW PORPS & TORPS
2
Cleared 510(K)
K
00
2897
TITANIUM MIDDLE EAR PROSTHESES
2
Cleared 510(K)
K
00
2464
SMITH & NEPHEW OFF-CENTERED PORP
2
Cleared 510(K)
K
00
2221
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
2
Cleared 510(K)
K
00
1142
AUDIO TECHNOLOGIES S:R.1
2
Cleared 510(K)
K
00
0858
WEHRS INCUS-STAPES
2
Cleared 510(K)
K
00
0256
CAP PORP, CAP TORP
2
Cleared 510(K)
K
99
3234
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
2
Cleared 510(K)
K
99
2839
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
2
Cleared 510(K)
K
99
1394
STAPES PROSTHESES
2
Cleared 510(K)
K
99
0923
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
2
Cleared 510(K)
K
98
1045
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
2
Cleared 510(K)
K
97
4365
MILLS INCUS HA SLEEVE
2
Cleared 510(K)
K
97
3356
K-PISTON WITH BAND HOOK /ANGULAR PISTON
2
Cleared 510(K)
K
97
2815
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
2
Cleared 510(K)
K
97
2734
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
2
Cleared 510(K)
K
97
2737
CAUSSE PISTON
2
Cleared 510(K)
K
97
2492
BELL PROSTHESIS (PARTIAL)
2
Cleared 510(K)
K
96
4909
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
2
Cleared 510(K)
K
96
2564
RICHARDS TOTAL/PARTIAL PROSTHESIS
2
Cleared 510(K)
K
96
4798
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
2
Cleared 510(K)
K
96
3752
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
2
Cleared 510(K)
K
94
5105
POLY/PLATINUM WIRE PISTON
2
Cleared 510(K)
K
95
5613
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
2
Cleared 510(K)
K
95
4517
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
2
Cleared 510(K)
K
95
2481
RICHARDS PORP
2
Cleared 510(K)
K
95
0984
HAPES MALLEABLE INCUS STAPES
2
Cleared 510(K)
K
95
0885
HAPEX MALLEABLE PORP
2
Cleared 510(K)
K
95
0887
HAPEX INCUS
2
Cleared 510(K)
K
95
0886
HAPEX PORP
2
Cleared 510(K)
K
94
5104
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
2
Cleared 510(K)
K
94
5108
POLY PISTON
2
Cleared 510(K)
K
94
5107
POLY-WIRE PISTON
2
Cleared 510(K)
K
92
5443
INCUDOSTAPEDIAL JOINT
2
Cleared 510(K)
K
91
5120
TEF/PLATINUM PISTON
2
Cleared 510(K)
K
91
5121
TEF/WIRE PISTON
2
Cleared 510(K)
K
91
3285
PTFE PISTON
2
Cleared 510(K)
K
91
3287
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
2
Cleared 510(K)
K
91
0685
WEHRS INCUS AND INCUS-STAPES PROSTHESES
2
Cleared 510(K)
K
91
3619
CERAVITAL MIDDLE EAR IMPLANT
2
Cleared 510(K)
K
89
5814
MICROTEK PISTON & WIRE PROSTHESES
2
Cleared 510(K)
K
89
3134
APACERAM OSSICULAR PROSTHESIS
2
Cleared 510(K)
K
88
3727
BUCKET PROSTHESIS PORP
2
Cleared 510(K)
K
87
2112
XOMED PLATINUM WIRE TEFLON PISTION
2
Cleared 510(K)
K
87
0766
PROSTHESIS WIRE
2
Cleared 510(K)
K
86
1369
INCUS/STAPES PROSTHESIS
2
Cleared 510(K)
K
86
0460
MICROTEK STAINLESS STEEL PISTON
2
Cleared 510(K)
K
84
4961
INCUS PROSTHESIS
2
Cleared 510(K)
K
84
1353
CAUSSE SPONGE BOAT
2
Cleared 510(K)
K
83
2540
DRUMTO STAPES PROSTHESIS
2
Cleared 510(K)
K
82
3483
STAINLESS STEEL PISTONS
2
Cleared 510(K)
K
82
3439
CAUSSE TEF-PISTON
2
Cleared 510(K)
K
82
3440
MCGEE MODIFIED STAINLESS STEEL PISTON
2
Cleared 510(K)
K
82
3429
FISCH MODIFIED TEF-WIRE PISTON
2
Cleared 510(K)
K
80
2873
SHEA LOCKING BAIL PROSTHESIS
2
Cleared 510(K)
K
80
2431
SCHURING OSSICLE CUP & COLUMELLA PROSTH.
2
Cleared 510(K)
K
76
0434
TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY
2
Cleared 510(K)
K
76
0437
CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
2
Cleared 510(K)
K
76
0435
PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
2
Cleared 510(K)
ETC
Mold, Middle-Ear
2
Product Code
ETD
Tube, Tympanostomy
2
Product Code
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
2
Product Code
EWL
Prosthesis, Laryngeal (Taub)
2
Product Code
FWN
Prosthesis, Larynx (Stents And Keels)
2
Product Code
JAZ
Prosthesis, Facial, Mandibular Implant
2
Product Code
JOF
Polymer, Ent Synthetic, Porous Polyethylene
2
Product Code
JXS
Block, Cutting, Ent, Sterile
1
Product Code
JXT
Crimper, Wire, Ent, Sterile
1
Product Code
JXW
Die, Wire Bending, Ent, Sterile
1
Product Code
JXX
Forceps, Wire Closure, Ent, Sterile
1
Product Code
JXY
Jig, Piston Cutting, Ent, Sterile
1
Product Code
JXZ
Punch, Gelfoam, Sterile
1
Product Code
JYA
Scissors, Wire Cutting, Ent, Sterile
1
Product Code
JYB
Vise, Ossicular Finger, Sterile
1
Product Code
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
2
Product Code
KHL
Hearing Aid, Master
2
Product Code
KLW
Masker, Tinnitus
2
Product Code
KLZ
Tube, Shunt, Endolymphatic With Valve
2
Product Code
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
2
Product Code
LBL
Tube, Tympanostomy, Porous Polyethylene
2
Product Code
LBM
Porous Polyethylene Ossicular Replacement
2
Product Code
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
2
Product Code
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
2
Product Code
LDG
Kit, Earmold, Impression
1
Product Code
LRB
Face Plate Hearing Aid
1
Product Code
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
1
Product Code
LWF
Dilator, Nasal
1
Product Code
LXB
Hearing Aid, Bone Conduction
2
Product Code
LZI
Device, Assistive Listening
2
Product Code
MAH
Hearing Aid, Bone Conduction, Implanted
2
Product Code
MCK
Device, Voice Amplification
2
Product Code
MIX
System, Vocal Cord Medialization
2
Product Code
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
2
Product Code
NIX
Hearing Aid, Air Conduction, Transcutaneous System
2
Product Code
NNN
Crimper, Wire, Ent, Non-Sterile
1
Product Code
NNO
Jig, Piston Cutting, Ent, Non-Sterile
1
Product Code
NNP
Die, Wire Bending, Ent, Non-Sterile
1
Product Code
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
1
Product Code
NNR
Block, Cutting, Ent, Non-Sterile
1
Product Code
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
1
Product Code
NNT
Punch, Gelfoam, Non-Sterile
1
Product Code
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
1
Product Code
NNV
Vise, Ossicular Finger, Non-Sterile
1
Product Code
OGS
Myringotomy Procedure Kit
2
Product Code
OSM
Hearing Aid, Air Conduction With Wireless Technology
2
Product Code
PFO
Active Implantable Bone Conduction Hearing System
2
Product Code
PLK
Tympanic Membrane Direct Contact Hearing Aid
2
Product Code
QDD
Self-Fitting Air-Conduction Hearing Aid
2
Product Code
QUF
Hearing Aid, Air-Conduction, Over The Counter
1
Product Code
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
2
Product Code
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
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—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
EN
/
subpart-d—prosthetic-devices
/
ETB
/
K002737
View Source
SMITH & NEPHEW PORPS & TORPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002737
510(k) Type
Traditional
Applicant
GYRUS ENT L.L.C.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/12/2000
Days to Decision
41 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
EPF
Hearing Aid, Group And Auditory Trainer
NEA
Cement, Ear, Nose And Throat
ESD
Hearing Aid, Air Conduction
ESE
Larynx, Artificial (Battery-Powered)
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
ESX
Tack, Sacculotomy (Cody Tack)
ESZ
Tube, Shunt, Endolymphatic
ETA
Replacement, Ossicular Prosthesis, Total
ETB
Prosthesis, Partial Ossicular Replacement
K
13
0512
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
K
11
2616
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
K
08
0070
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K
06
3374
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
K
06
1853
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
K
06
0518
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K
03
3554
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
K
02
1479
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
K
01
3573
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
K
01
0442
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
K
00
3214
SMITH & NEPHEW PISTONS
K
00
2737
SMITH & NEPHEW PORPS & TORPS
K
00
2897
TITANIUM MIDDLE EAR PROSTHESES
K
00
2464
SMITH & NEPHEW OFF-CENTERED PORP
K
00
2221
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
K
00
1142
AUDIO TECHNOLOGIES S:R.1
K
00
0858
WEHRS INCUS-STAPES
K
00
0256
CAP PORP, CAP TORP
K
99
3234
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K
99
2839
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
K
99
1394
STAPES PROSTHESES
K
99
0923
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
K
98
1045
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K
97
4365
MILLS INCUS HA SLEEVE
K
97
3356
K-PISTON WITH BAND HOOK /ANGULAR PISTON
K
97
2815
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K
97
2734
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K
97
2737
CAUSSE PISTON
K
97
2492
BELL PROSTHESIS (PARTIAL)
K
96
4909
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K
96
2564
RICHARDS TOTAL/PARTIAL PROSTHESIS
K
96
4798
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K
96
3752
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K
94
5105
POLY/PLATINUM WIRE PISTON
K
95
5613
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K
95
4517
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
K
95
2481
RICHARDS PORP
K
95
0984
HAPES MALLEABLE INCUS STAPES
K
95
0885
HAPEX MALLEABLE PORP
K
95
0887
HAPEX INCUS
K
95
0886
HAPEX PORP
K
94
5104
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
K
94
5108
POLY PISTON
K
94
5107
POLY-WIRE PISTON
K
92
5443
INCUDOSTAPEDIAL JOINT
K
91
5120
TEF/PLATINUM PISTON
K
91
5121
TEF/WIRE PISTON
K
91
3285
PTFE PISTON
K
91
3287
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
K
91
0685
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K
91
3619
CERAVITAL MIDDLE EAR IMPLANT
K
89
5814
MICROTEK PISTON & WIRE PROSTHESES
K
89
3134
APACERAM OSSICULAR PROSTHESIS
K
88
3727
BUCKET PROSTHESIS PORP
K
87
2112
XOMED PLATINUM WIRE TEFLON PISTION
K
87
0766
PROSTHESIS WIRE
K
86
1369
INCUS/STAPES PROSTHESIS
K
86
0460
MICROTEK STAINLESS STEEL PISTON
K
84
4961
INCUS PROSTHESIS
K
84
1353
CAUSSE SPONGE BOAT
K
83
2540
DRUMTO STAPES PROSTHESIS
K
82
3483
STAINLESS STEEL PISTONS
K
82
3439
CAUSSE TEF-PISTON
K
82
3440
MCGEE MODIFIED STAINLESS STEEL PISTON
K
82
3429
FISCH MODIFIED TEF-WIRE PISTON
K
80
2873
SHEA LOCKING BAIL PROSTHESIS
K
80
2431
SCHURING OSSICLE CUP & COLUMELLA PROSTH.
K
76
0434
TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY
K
76
0437
CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
K
76
0435
PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
ETC
Mold, Middle-Ear
ETD
Tube, Tympanostomy
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
EWL
Prosthesis, Laryngeal (Taub)
FWN
Prosthesis, Larynx (Stents And Keels)
JAZ
Prosthesis, Facial, Mandibular Implant
JOF
Polymer, Ent Synthetic, Porous Polyethylene
JXS
Block, Cutting, Ent, Sterile
JXT
Crimper, Wire, Ent, Sterile
JXW
Die, Wire Bending, Ent, Sterile
JXX
Forceps, Wire Closure, Ent, Sterile
JXY
Jig, Piston Cutting, Ent, Sterile
JXZ
Punch, Gelfoam, Sterile
JYA
Scissors, Wire Cutting, Ent, Sterile
JYB
Vise, Ossicular Finger, Sterile
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
KHL
Hearing Aid, Master
KLW
Masker, Tinnitus
KLZ
Tube, Shunt, Endolymphatic With Valve
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
LBL
Tube, Tympanostomy, Porous Polyethylene
LBM
Porous Polyethylene Ossicular Replacement
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
LDG
Kit, Earmold, Impression
LRB
Face Plate Hearing Aid
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
LWF
Dilator, Nasal
LXB
Hearing Aid, Bone Conduction
LZI
Device, Assistive Listening
MAH
Hearing Aid, Bone Conduction, Implanted
MCK
Device, Voice Amplification
MIX
System, Vocal Cord Medialization
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
NIX
Hearing Aid, Air Conduction, Transcutaneous System
NNN
Crimper, Wire, Ent, Non-Sterile
NNO
Jig, Piston Cutting, Ent, Non-Sterile
NNP
Die, Wire Bending, Ent, Non-Sterile
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
NNR
Block, Cutting, Ent, Non-Sterile
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
NNT
Punch, Gelfoam, Non-Sterile
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
NNV
Vise, Ossicular Finger, Non-Sterile
OGS
Myringotomy Procedure Kit
OSM
Hearing Aid, Air Conduction With Wireless Technology
PFO
Active Implantable Bone Conduction Hearing System
PLK
Tympanic Membrane Direct Contact Hearing Aid
QDD
Self-Fitting Air-Conduction Hearing Aid
QUF
Hearing Aid, Air-Conduction, Over The Counter
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
subpart-d—prosthetic-devices
/
ETB
/
K002737
View Source
SMITH & NEPHEW PORPS & TORPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002737
510(k) Type
Traditional
Applicant
GYRUS ENT L.L.C.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/12/2000
Days to Decision
41 days
Submission Type
Summary