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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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
Miscellaneous
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
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
FPX
Strip, Adhesive, Closure, Skin
1
Product Code
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
K
00
1240
SERAGARD INJECTION PATCH
1
Cleared 510(K)
K
98
3368
CARE BAND ANTIBACTERIAL BANDAGES
1
Cleared 510(K)
K
97
2914
SYVEK PATCH
1
Cleared 510(K)
K
94
3314
ADHESIVE BANDAGES WITH OTC DRUG
1
Cleared 510(K)
K
95
2606
TARGETT PATCH
1
Cleared 510(K)
K
95
4007
PARALLEL
1
Cleared 510(K)
K
94
4587
DERMIVIEW HYPOALLERGENIC CLEAR TAPE
1
Cleared 510(K)
K
94
4588
STERILE PLASTIC DRESSING
1
Cleared 510(K)
K
94
1788
BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP
1
Cleared 510(K)
K
94
0536
BAND-AID(TM) BRAND ADHESIVE BANDAGE
1
Cleared 510(K)
K
94
0798
SHIPPERT PRESSURE BANDAGE
1
Cleared 510(K)
K
94
1389
EMPI TAPE PATCHES
1
Cleared 510(K)
K
94
2383
DERMIVIEW CLEAR TAPE
1
Cleared 510(K)
K
94
0378
COVERLET ADHESIVE DRESSING
1
Cleared 510(K)
K
94
1499
KIT PAK DRESSING CHANGE TRAY
1
Cleared 510(K)
K
94
1943
SURGICAL ADHESIVE TAPE
1
Cleared 510(K)
K
94
1379
ACE SPORTS TAPE
1
Cleared 510(K)
K
93
5948
CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM
1
Cleared 510(K)
K
93
2457
SPYROGEL WOUND DRESSING
1
Cleared 510(K)
K
93
5725
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
1
Cleared 510(K)
K
93
0457
MEDIMAC BANDAGE
1
Cleared 510(K)
K
93
2422
3M TEGADERM HP TRANSPARENT DRESSING
1
Cleared 510(K)
K
93
2743
MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
1
Cleared 510(K)
K
93
1886
TISSUE ISOLATION AND RETRIEVAL BAG
1
Cleared 510(K)
K
92
4192
I.V. START KIT (AHC-50-54954
1
Cleared 510(K)
K
92
2441
SURESEAL BANDAGE
1
Cleared 510(K)
K
93
2602
ADHESIVE BANDAGES
1
Cleared 510(K)
K
92
4794
TRANSPARENT ADHESIVE DRESSING
1
Cleared 510(K)
K
92
3319
SHAWNEE PRODUCT KIT IV
1
Cleared 510(K)
K
92
3235
BIOCLUSIVE MVP TRANSPARENT DRESSING
1
Cleared 510(K)
K
92
5384
ISOPORE(TM) TAPE, MODIFICATION
1
Cleared 510(K)
K
92
6264
MEDICOTEST SKIN FIX
1
Cleared 510(K)
K
92
3662
INGROWN TOENAIL PAD
1
Cleared 510(K)
K
92
1761
SHAWNEE PRODUCTS KIT II
1
Cleared 510(K)
K
92
3358
LC STRIP
1
Cleared 510(K)
K
92
2228
2ND SKIN STERILE ADHESIVE STRIP
1
Cleared 510(K)
K
92
3400
DERMCO A-I
1
Cleared 510(K)
K
92
2897
STRAPPAL
1
Cleared 510(K)
K
92
2959
ISOPORE TAPE
1
Cleared 510(K)
K
92
3404
LUEKOFLEX SURGICAL TAPE
1
Cleared 510(K)
K
92
3300
DEROYAL EYE DRESSING
1
Cleared 510(K)
K
92
0675
DUODERM SUSTAINED COMPRESSION BANDAGE
1
Cleared 510(K)
K
92
1760
TRICOPLAST
1
Cleared 510(K)
K
92
1759
ACRYLASTIC
1
Cleared 510(K)
K
91
4733
TTL MEDICATED DRESSING
1
Cleared 510(K)
K
91
5446
STRETCH WRAP
1
Cleared 510(K)
K
91
5358
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
1
Cleared 510(K)
K
92
0182
MARION WINDOW
1
Cleared 510(K)
K
91
5057
CANN-HOLD
1
Cleared 510(K)
K
91
4596
SURGICAL CLOTH TAPE (HEALRITE)
1
Cleared 510(K)
K
91
4597
SURGICAL MICROPOROUS TAPE (MICROCEL)
1
Cleared 510(K)
K
91
4315
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
1
Cleared 510(K)
K
91
5565
IMMOBILE
1
Cleared 510(K)
K
91
4245
DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
1
Cleared 510(K)
K
91
4912
PROMEON 63B SURGICAL TAPE
1
Cleared 510(K)
K
91
2623
MEDICAL TAPE
1
Cleared 510(K)
K
91
2160
BUTTERFLY DRESSING
1
Cleared 510(K)
K
91
2518
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE
1
Cleared 510(K)
K
91
2550
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
1
Cleared 510(K)
K
91
2520
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
1
Cleared 510(K)
K
91
1682
AIRSTRIP FIRST AID & POST-OP DRESSING
1
Cleared 510(K)
K
91
0657
QUALTEX ISLAND DRESSING
1
Cleared 510(K)
K
89
5920
VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS
1
Cleared 510(K)
K
91
0678
TRO-GARD
1
Cleared 510(K)
K
91
0436
ELASTIC ADHESIVE BANDAGE
1
Cleared 510(K)
K
90
4904
MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION
1
Cleared 510(K)
K
90
4445
OMIBAND
1
Cleared 510(K)
K
90
5022
AQUA-GARD WATERPROOF WOUND PATCH
1
Cleared 510(K)
K
90
3823
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
1
Cleared 510(K)
K
90
4500
ELASTOPLAST
1
Cleared 510(K)
K
89
6068
TIPSTOP(TM)
1
Cleared 510(K)
K
90
1777
3M FIRST AID BANDAGE FOR MINOR WOUNDS
1
Cleared 510(K)
K
90
1845
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
1
Cleared 510(K)
K
90
1879
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
1
Cleared 510(K)
K
90
2010
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
1
Cleared 510(K)
K
90
0447
DUODERM* ADHESIVE COMPRESSION BANDAGE
1
Cleared 510(K)
K
89
6455
VITACHOICE WOUND DRESSING
1
Cleared 510(K)
K
89
6891
LEUKOSILK(TM) SURGICAL TAPE
1
Cleared 510(K)
K
89
6733
VACCON
1
Cleared 510(K)
K
89
6358
VARI/MOIST WOUND DRESSING
1
Cleared 510(K)
K
89
5884
BANDAGE REMOVAL STRIP
1
Cleared 510(K)
K
89
5408
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)
1
Cleared 510(K)
K
89
4367
LEUKOSPORT(TM) ADHESIVE TAPE
1
Cleared 510(K)
K
89
2450
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
1
Cleared 510(K)
K
89
5353
OPSITE I.V. 3000
1
Cleared 510(K)
K
89
4916
COMFEEL TRANSPARENT DRESSING
1
Cleared 510(K)
K
89
5376
ACTIDERM (TM) DERMATOLOGICAL PATCH
1
Cleared 510(K)
K
89
3569
QUICK CHANGE MONTGOMERY STRAP
1
Cleared 510(K)
K
89
4274
EXUSORB TRANSPARENT DRESSING
1
Cleared 510(K)
K
89
0917
PHOENIX DRAPES WITH MICROBAN
1
Cleared 510(K)
K
89
4147
VISULIN TRANSPARENT ADHESIVE DRESSING
1
Cleared 510(K)
K
89
3900
PRIMAPORE I.V.
1
Cleared 510(K)
K
88
5205
AQUADERM
1
Cleared 510(K)
K
88
3660
DERMASTRIP
1
Cleared 510(K)
K
88
3983
SANIFIX
1
Cleared 510(K)
K
88
4108
MACROPORE MEDICAL/SURGICAL PAPER TAPE
1
Cleared 510(K)
K
88
1397
SANAPLAST
1
Cleared 510(K)
K
88
1509
LEUKOPOR(TM) SURGICAL TAPE
1
Cleared 510(K)
K
88
0207
EXPANDOVER ELASTIC BANDAGE
1
Cleared 510(K)
K
88
0964
POLYDERM PEC(TM), POROUS ELASTIC COVER
1
Cleared 510(K)
K
87
2975
LIGHTPLAST(TM)
1
Cleared 510(K)
K
87
2594
ANDOVER MOLESKIN
1
Cleared 510(K)
K
87
2593
ANDOVER ADHESIVE TAPE, SURGICAL
1
Cleared 510(K)
K
87
0900
THE GRIPPER SEAL(TM)
1
Cleared 510(K)
K
87
0092
MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM
1
Cleared 510(K)
K
87
0093
MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM
1
Cleared 510(K)
K
87
0021
MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE
1
Cleared 510(K)
K
87
0091
IV SECUREMENT DEVICE USING PCCE THERMO. FILM
1
Cleared 510(K)
K
87
0090
IV SECUREMENT DEVICE USING HYTREL THERMO. FILM
1
Cleared 510(K)
K
87
0020
IV SECUREMENT DEVICE
1
Cleared 510(K)
K
86
4076
HERCON ANTISEPTIC TRANSPARENT DRESSING
1
Cleared 510(K)
K
86
4160
LEUKOPLAST(R) POROUS AND SPORT TAPE
1
Cleared 510(K)
K
86
3753
FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000
1
Cleared 510(K)
K
86
0804
MEDICAL ADHESIVE TAPE
1
Cleared 510(K)
K
85
4006
PLASTELAST AND/OR ELASTOPLASTE
1
Cleared 510(K)
K
85
3820
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
1
Cleared 510(K)
K
85
3645
NITTO SURGICAL CLOTH TAPE ST-330
1
Cleared 510(K)
K
85
3644
NITTO SURGICAL PLASTIC TAPE ST-356
1
Cleared 510(K)
K
85
3646
NITTO SURGICAL NON-WOVEN TAPE ST-320
1
Cleared 510(K)
K
85
3647
NITTO SURGICAL PAPER TAPE ST-310
1
Cleared 510(K)
K
85
2408
EXTRA LARGE ADHESIVE STRIPS
1
Cleared 510(K)
K
85
2462
TRICOT ADHESIVE BANDAGE
1
Cleared 510(K)
K
85
0529
SHEER ADHESIVE BANDAGES, STERILE
1
Cleared 510(K)
K
85
0133
VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
1
Cleared 510(K)
K
84
3874
LEUKOPOR SURGICAL TAPE
1
Cleared 510(K)
K
84
3873
LEUKOFIX R
1
Cleared 510(K)
K
84
3876
LEUKOFLEX SURGICAL TAPE
1
Cleared 510(K)
K
84
3875
LEUKOSILK
1
Cleared 510(K)
K
84
4463
DERMIDRESS
1
Cleared 510(K)
K
84
2946
ACU-PATCH
1
Cleared 510(K)
K
84
3587
PETIT BANDS
1
Cleared 510(K)
K
84
2511
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
1
Cleared 510(K)
K
84
2301
DISPOSABLE LATEX BANDAGE
1
Cleared 510(K)
K
84
0951
FIRST AID BANDAGE
1
Cleared 510(K)
K
84
0950
ZINC OXIDE TAPE
1
Cleared 510(K)
K
84
0609
SKIN TECH. ISOTEX 86L
1
Cleared 510(K)
K
84
0448
MEDICAL ADHESIVE FOAM TAPE
1
Cleared 510(K)
K
84
0446
MEDICAL TAPE
1
Cleared 510(K)
K
84
0949
CLEAR PLASTIC-HYPOALLERGENIC
1
Cleared 510(K)
K
84
0947
CLOTH-HYPOALLERGENIC
1
Cleared 510(K)
K
84
0447
MICROPOROUS MED. ADHESIVE TAPE
1
Cleared 510(K)
K
84
1899
FIRST RESPONSE EMERG. MEDICAL SYS BONES
1
Cleared 510(K)
K
84
1897
FIRST RESPONSE EMERG. MEDICAL SYSTEM
1
Cleared 510(K)
K
83
3688
SUTURE REMOVAL KITS STERILE
1
Cleared 510(K)
K
83
3954
MELOLITE
1
Cleared 510(K)
K
83
3916
HYPAFIX DRESSING RETENTION SHEET
1
Cleared 510(K)
K
83
3731
BREATHABLE OVERWRAY BANDAGE NON-ELAS
1
Cleared 510(K)
K
83
3590
DRESS, SURGICAL ADHESIVE
1
Cleared 510(K)
K
83
3120
ONE TIME COMPOUND BENZOIN TINCTURE-
1
Cleared 510(K)
K
83
2544
SYSTENET
1
Cleared 510(K)
K
82
2824
ADHESIVE TAPE/FIRST-BAND
1
Cleared 510(K)
K
81
3265
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
1
Cleared 510(K)
K
82
3076
SATOBAN FIRST AID TAPE
1
Cleared 510(K)
K
82
1490
SILKAFIX ADHESIVE PLASTER
1
Cleared 510(K)
K
82
1257
SELOFIX
1
Cleared 510(K)
K
82
0872
CURITY SHETHOSCOPE SECURING PADS
1
Cleared 510(K)
K
82
0018
COMFEEL PROTECTIVE SHEET
1
Cleared 510(K)
K
81
3364
MEDICAL TAPE (MULTIPLE)
1
Cleared 510(K)
K
81
3361
ADHESIVE STRIP(MULTIPLE)
1
Cleared 510(K)
K
81
3421
NON-ADHER PADS
1
Cleared 510(K)
K
81
3124
ETHICON* SKIN CLOSURE TAPE
1
Cleared 510(K)
K
81
1291
TEGADERM TRANSPARENT DRESSING
1
Cleared 510(K)
K
81
0896
VENTI-GARD JR.
1
Cleared 510(K)
K
81
0623
BAND-AID KITCHEN ASSORTMENT
1
Cleared 510(K)
K
81
0580
SCOTCH BRAND ADHESIVE TAPE
1
Cleared 510(K)
K
81
0126
CURITY CURAD BANDAGES
1
Cleared 510(K)
K
81
0053
JOHNSON & JOHNSON ADHESIVE FILM DRESSING
1
Cleared 510(K)
K
80
3153
ELASTIC ADHESIVE BANDAGES
1
Cleared 510(K)
K
80
2795
ORTHOPEDIC PADDING
1
Cleared 510(K)
K
80
2752
POROUS, BREATHING TAPE W/RELEASE LINER
1
Cleared 510(K)
K
80
2764
PLASTIC ADHESIVE BANDAGE
1
Cleared 510(K)
K
80
2242
3M HI-STRENGTH MED. TAPE #1534
1
Cleared 510(K)
K
80
2073
MUELLER STRETCH M TAPE
1
Cleared 510(K)
K
80
1794
ELASTIC ADHESIVE BANDAGES(STERILE)
1
Cleared 510(K)
K
80
0907
TOMAC WET DRESSING WARMER
1
Cleared 510(K)
K
79
2666
LEUKOPOR
1
Cleared 510(K)
K
79
2103
HYPO-ALLERGENIC PAPER ADHESIVE TAPE
1
Cleared 510(K)
K
79
2102
HYPO-ALLERGENIC CLOTH ADHESIVE TAPE
1
Cleared 510(K)
K
79
1886
I.V. CARE KIT
1
Cleared 510(K)
K
79
1885
I.V. START SET
1
Cleared 510(K)
K
79
1288
YELLOW ALERT SYSTEM
1
Cleared 510(K)
K
77
0362
TAPE, DERMICEL, CLOTH
1
Cleared 510(K)
K
76
1336
BAND-AID BRAND PLASTIC BANDAGES
1
Cleared 510(K)
K
76
1335
BAND-AID BRAND SHEER BANDAGES
1
Cleared 510(K)
KMF
Bandage, Liquid
1
Product Code
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
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-f—general-hospital-and-personal-use-therapeutic-devices
/
KGX
/
K935725
View Source
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K935725
510(k) Type
Traditional
Applicant
DEROYAL INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/1994
Days to Decision
65 days
Submission Type
Statement
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
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
FPX
Strip, Adhesive, Closure, Skin
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
K
00
1240
SERAGARD INJECTION PATCH
K
98
3368
CARE BAND ANTIBACTERIAL BANDAGES
K
97
2914
SYVEK PATCH
K
94
3314
ADHESIVE BANDAGES WITH OTC DRUG
K
95
2606
TARGETT PATCH
K
95
4007
PARALLEL
K
94
4587
DERMIVIEW HYPOALLERGENIC CLEAR TAPE
K
94
4588
STERILE PLASTIC DRESSING
K
94
1788
BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP
K
94
0536
BAND-AID(TM) BRAND ADHESIVE BANDAGE
K
94
0798
SHIPPERT PRESSURE BANDAGE
K
94
1389
EMPI TAPE PATCHES
K
94
2383
DERMIVIEW CLEAR TAPE
K
94
0378
COVERLET ADHESIVE DRESSING
K
94
1499
KIT PAK DRESSING CHANGE TRAY
K
94
1943
SURGICAL ADHESIVE TAPE
K
94
1379
ACE SPORTS TAPE
K
93
5948
CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM
K
93
2457
SPYROGEL WOUND DRESSING
K
93
5725
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K
93
0457
MEDIMAC BANDAGE
K
93
2422
3M TEGADERM HP TRANSPARENT DRESSING
K
93
2743
MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
K
93
1886
TISSUE ISOLATION AND RETRIEVAL BAG
K
92
4192
I.V. START KIT (AHC-50-54954
K
92
2441
SURESEAL BANDAGE
K
93
2602
ADHESIVE BANDAGES
K
92
4794
TRANSPARENT ADHESIVE DRESSING
K
92
3319
SHAWNEE PRODUCT KIT IV
K
92
3235
BIOCLUSIVE MVP TRANSPARENT DRESSING
K
92
5384
ISOPORE(TM) TAPE, MODIFICATION
K
92
6264
MEDICOTEST SKIN FIX
K
92
3662
INGROWN TOENAIL PAD
K
92
1761
SHAWNEE PRODUCTS KIT II
K
92
3358
LC STRIP
K
92
2228
2ND SKIN STERILE ADHESIVE STRIP
K
92
3400
DERMCO A-I
K
92
2897
STRAPPAL
K
92
2959
ISOPORE TAPE
K
92
3404
LUEKOFLEX SURGICAL TAPE
K
92
3300
DEROYAL EYE DRESSING
K
92
0675
DUODERM SUSTAINED COMPRESSION BANDAGE
K
92
1760
TRICOPLAST
K
92
1759
ACRYLASTIC
K
91
4733
TTL MEDICATED DRESSING
K
91
5446
STRETCH WRAP
K
91
5358
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K
92
0182
MARION WINDOW
K
91
5057
CANN-HOLD
K
91
4596
SURGICAL CLOTH TAPE (HEALRITE)
K
91
4597
SURGICAL MICROPOROUS TAPE (MICROCEL)
K
91
4315
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
K
91
5565
IMMOBILE
K
91
4245
DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
K
91
4912
PROMEON 63B SURGICAL TAPE
K
91
2623
MEDICAL TAPE
K
91
2160
BUTTERFLY DRESSING
K
91
2518
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE
K
91
2550
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
K
91
2520
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K
91
1682
AIRSTRIP FIRST AID & POST-OP DRESSING
K
91
0657
QUALTEX ISLAND DRESSING
K
89
5920
VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS
K
91
0678
TRO-GARD
K
91
0436
ELASTIC ADHESIVE BANDAGE
K
90
4904
MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION
K
90
4445
OMIBAND
K
90
5022
AQUA-GARD WATERPROOF WOUND PATCH
K
90
3823
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
K
90
4500
ELASTOPLAST
K
89
6068
TIPSTOP(TM)
K
90
1777
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K
90
1845
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K
90
1879
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K
90
2010
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K
90
0447
DUODERM* ADHESIVE COMPRESSION BANDAGE
K
89
6455
VITACHOICE WOUND DRESSING
K
89
6891
LEUKOSILK(TM) SURGICAL TAPE
K
89
6733
VACCON
K
89
6358
VARI/MOIST WOUND DRESSING
K
89
5884
BANDAGE REMOVAL STRIP
K
89
5408
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)
K
89
4367
LEUKOSPORT(TM) ADHESIVE TAPE
K
89
2450
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K
89
5353
OPSITE I.V. 3000
K
89
4916
COMFEEL TRANSPARENT DRESSING
K
89
5376
ACTIDERM (TM) DERMATOLOGICAL PATCH
K
89
3569
QUICK CHANGE MONTGOMERY STRAP
K
89
4274
EXUSORB TRANSPARENT DRESSING
K
89
0917
PHOENIX DRAPES WITH MICROBAN
K
89
4147
VISULIN TRANSPARENT ADHESIVE DRESSING
K
89
3900
PRIMAPORE I.V.
K
88
5205
AQUADERM
K
88
3660
DERMASTRIP
K
88
3983
SANIFIX
K
88
4108
MACROPORE MEDICAL/SURGICAL PAPER TAPE
K
88
1397
SANAPLAST
K
88
1509
LEUKOPOR(TM) SURGICAL TAPE
K
88
0207
EXPANDOVER ELASTIC BANDAGE
K
88
0964
POLYDERM PEC(TM), POROUS ELASTIC COVER
K
87
2975
LIGHTPLAST(TM)
K
87
2594
ANDOVER MOLESKIN
K
87
2593
ANDOVER ADHESIVE TAPE, SURGICAL
K
87
0900
THE GRIPPER SEAL(TM)
K
87
0092
MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM
K
87
0093
MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM
K
87
0021
MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE
K
87
0091
IV SECUREMENT DEVICE USING PCCE THERMO. FILM
K
87
0090
IV SECUREMENT DEVICE USING HYTREL THERMO. FILM
K
87
0020
IV SECUREMENT DEVICE
K
86
4076
HERCON ANTISEPTIC TRANSPARENT DRESSING
K
86
4160
LEUKOPLAST(R) POROUS AND SPORT TAPE
K
86
3753
FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000
K
86
0804
MEDICAL ADHESIVE TAPE
K
85
4006
PLASTELAST AND/OR ELASTOPLASTE
K
85
3820
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K
85
3645
NITTO SURGICAL CLOTH TAPE ST-330
K
85
3644
NITTO SURGICAL PLASTIC TAPE ST-356
K
85
3646
NITTO SURGICAL NON-WOVEN TAPE ST-320
K
85
3647
NITTO SURGICAL PAPER TAPE ST-310
K
85
2408
EXTRA LARGE ADHESIVE STRIPS
K
85
2462
TRICOT ADHESIVE BANDAGE
K
85
0529
SHEER ADHESIVE BANDAGES, STERILE
K
85
0133
VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
K
84
3874
LEUKOPOR SURGICAL TAPE
K
84
3873
LEUKOFIX R
K
84
3876
LEUKOFLEX SURGICAL TAPE
K
84
3875
LEUKOSILK
K
84
4463
DERMIDRESS
K
84
2946
ACU-PATCH
K
84
3587
PETIT BANDS
K
84
2511
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K
84
2301
DISPOSABLE LATEX BANDAGE
K
84
0951
FIRST AID BANDAGE
K
84
0950
ZINC OXIDE TAPE
K
84
0609
SKIN TECH. ISOTEX 86L
K
84
0448
MEDICAL ADHESIVE FOAM TAPE
K
84
0446
MEDICAL TAPE
K
84
0949
CLEAR PLASTIC-HYPOALLERGENIC
K
84
0947
CLOTH-HYPOALLERGENIC
K
84
0447
MICROPOROUS MED. ADHESIVE TAPE
K
84
1899
FIRST RESPONSE EMERG. MEDICAL SYS BONES
K
84
1897
FIRST RESPONSE EMERG. MEDICAL SYSTEM
K
83
3688
SUTURE REMOVAL KITS STERILE
K
83
3954
MELOLITE
K
83
3916
HYPAFIX DRESSING RETENTION SHEET
K
83
3731
BREATHABLE OVERWRAY BANDAGE NON-ELAS
K
83
3590
DRESS, SURGICAL ADHESIVE
K
83
3120
ONE TIME COMPOUND BENZOIN TINCTURE-
K
83
2544
SYSTENET
K
82
2824
ADHESIVE TAPE/FIRST-BAND
K
81
3265
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K
82
3076
SATOBAN FIRST AID TAPE
K
82
1490
SILKAFIX ADHESIVE PLASTER
K
82
1257
SELOFIX
K
82
0872
CURITY SHETHOSCOPE SECURING PADS
K
82
0018
COMFEEL PROTECTIVE SHEET
K
81
3364
MEDICAL TAPE (MULTIPLE)
K
81
3361
ADHESIVE STRIP(MULTIPLE)
K
81
3421
NON-ADHER PADS
K
81
3124
ETHICON* SKIN CLOSURE TAPE
K
81
1291
TEGADERM TRANSPARENT DRESSING
K
81
0896
VENTI-GARD JR.
K
81
0623
BAND-AID KITCHEN ASSORTMENT
K
81
0580
SCOTCH BRAND ADHESIVE TAPE
K
81
0126
CURITY CURAD BANDAGES
K
81
0053
JOHNSON & JOHNSON ADHESIVE FILM DRESSING
K
80
3153
ELASTIC ADHESIVE BANDAGES
K
80
2795
ORTHOPEDIC PADDING
K
80
2752
POROUS, BREATHING TAPE W/RELEASE LINER
K
80
2764
PLASTIC ADHESIVE BANDAGE
K
80
2242
3M HI-STRENGTH MED. TAPE #1534
K
80
2073
MUELLER STRETCH M TAPE
K
80
1794
ELASTIC ADHESIVE BANDAGES(STERILE)
K
80
0907
TOMAC WET DRESSING WARMER
K
79
2666
LEUKOPOR
K
79
2103
HYPO-ALLERGENIC PAPER ADHESIVE TAPE
K
79
2102
HYPO-ALLERGENIC CLOTH ADHESIVE TAPE
K
79
1886
I.V. CARE KIT
K
79
1885
I.V. START SET
K
79
1288
YELLOW ALERT SYSTEM
K
77
0362
TAPE, DERMICEL, CLOTH
K
76
1336
BAND-AID BRAND PLASTIC BANDAGES
K
76
1335
BAND-AID BRAND SHEER BANDAGES
KMF
Bandage, Liquid
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
KGX
/
K935725
View Source
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K935725
510(k) Type
Traditional
Applicant
DEROYAL INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/1994
Days to Decision
65 days
Submission Type
Statement