Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- FPXStrip, Adhesive, Closure, Skin1Product Code
- FPYSheet, Burn1Product Code
- KGXTape And Bandage, Adhesive1Product Code
- K001240SERAGARD INJECTION PATCH1Cleared 510(K)
- K983368CARE BAND ANTIBACTERIAL BANDAGES1Cleared 510(K)
- K972914SYVEK PATCH1Cleared 510(K)
- K943314ADHESIVE BANDAGES WITH OTC DRUG1Cleared 510(K)
- K952606TARGETT PATCH1Cleared 510(K)
- K954007PARALLEL1Cleared 510(K)
- K944587DERMIVIEW HYPOALLERGENIC CLEAR TAPE1Cleared 510(K)
- K944588STERILE PLASTIC DRESSING1Cleared 510(K)
- K941788BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP1Cleared 510(K)
- K940536BAND-AID(TM) BRAND ADHESIVE BANDAGE1Cleared 510(K)
- K940798SHIPPERT PRESSURE BANDAGE1Cleared 510(K)
- K941389EMPI TAPE PATCHES1Cleared 510(K)
- K942383DERMIVIEW CLEAR TAPE1Cleared 510(K)
- K940378COVERLET ADHESIVE DRESSING1Cleared 510(K)
- K941499KIT PAK DRESSING CHANGE TRAY1Cleared 510(K)
- K941943SURGICAL ADHESIVE TAPE1Cleared 510(K)
- K941379ACE SPORTS TAPE1Cleared 510(K)
- K935948CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM1Cleared 510(K)
- K932457SPYROGEL WOUND DRESSING1Cleared 510(K)
- K935725EPISEAL ADHESIVE WOUND CLOSURE STRIPS1Cleared 510(K)
- K930457MEDIMAC BANDAGE1Cleared 510(K)
- K9324223M TEGADERM HP TRANSPARENT DRESSING1Cleared 510(K)
- K932743MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION1Cleared 510(K)
- K931886TISSUE ISOLATION AND RETRIEVAL BAG1Cleared 510(K)
- K924192I.V. START KIT (AHC-50-549541Cleared 510(K)
- K922441SURESEAL BANDAGE1Cleared 510(K)
- K932602ADHESIVE BANDAGES1Cleared 510(K)
- K924794TRANSPARENT ADHESIVE DRESSING1Cleared 510(K)
- K923319SHAWNEE PRODUCT KIT IV1Cleared 510(K)
- K923235BIOCLUSIVE MVP TRANSPARENT DRESSING1Cleared 510(K)
- K925384ISOPORE(TM) TAPE, MODIFICATION1Cleared 510(K)
- K926264MEDICOTEST SKIN FIX1Cleared 510(K)
- K923662INGROWN TOENAIL PAD1Cleared 510(K)
- K921761SHAWNEE PRODUCTS KIT II1Cleared 510(K)
- K923358LC STRIP1Cleared 510(K)
- K9222282ND SKIN STERILE ADHESIVE STRIP1Cleared 510(K)
- K923400DERMCO A-I1Cleared 510(K)
- K922897STRAPPAL1Cleared 510(K)
- K922959ISOPORE TAPE1Cleared 510(K)
- K923404LUEKOFLEX SURGICAL TAPE1Cleared 510(K)
- K923300DEROYAL EYE DRESSING1Cleared 510(K)
- K920675DUODERM SUSTAINED COMPRESSION BANDAGE1Cleared 510(K)
- K921760TRICOPLAST1Cleared 510(K)
- K921759ACRYLASTIC1Cleared 510(K)
- K914733TTL MEDICATED DRESSING1Cleared 510(K)
- K915446STRETCH WRAP1Cleared 510(K)
- K915358PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH1Cleared 510(K)
- K920182MARION WINDOW1Cleared 510(K)
- K915057CANN-HOLD1Cleared 510(K)
- K914597SURGICAL MICROPOROUS TAPE (MICROCEL)1Cleared 510(K)
- K914596SURGICAL CLOTH TAPE (HEALRITE)1Cleared 510(K)
- K914315OPTICAL CATHETER INTRODUCER SETS, MODIFICATION1Cleared 510(K)
- K915565IMMOBILE1Cleared 510(K)
- K914245DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)1Cleared 510(K)
- K914912PROMEON 63B SURGICAL TAPE1Cleared 510(K)
- K912623MEDICAL TAPE1Cleared 510(K)
- K912160BUTTERFLY DRESSING1Cleared 510(K)
- K912518CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE1Cleared 510(K)
- K912550DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED1Cleared 510(K)
- K9125203M WATER DISPERSIBLE ADHESIVE TAPE, 98XX1Cleared 510(K)
- K911682AIRSTRIP FIRST AID & POST-OP DRESSING1Cleared 510(K)
- K910657QUALTEX ISLAND DRESSING1Cleared 510(K)
- K895920VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS1Cleared 510(K)
- K910678TRO-GARD1Cleared 510(K)
- K910436ELASTIC ADHESIVE BANDAGE1Cleared 510(K)
- K904904MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION1Cleared 510(K)
- K904445OMIBAND1Cleared 510(K)
- K905022AQUA-GARD WATERPROOF WOUND PATCH1Cleared 510(K)
- K903823SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE1Cleared 510(K)
- K904500ELASTOPLAST1Cleared 510(K)
- K896068TIPSTOP(TM)1Cleared 510(K)
- K9017773M FIRST AID BANDAGE FOR MINOR WOUNDS1Cleared 510(K)
- K901845TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX1Cleared 510(K)
- K901879INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)1Cleared 510(K)
- K902010VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE1Cleared 510(K)
- K900447DUODERM* ADHESIVE COMPRESSION BANDAGE1Cleared 510(K)
- K896455VITACHOICE WOUND DRESSING1Cleared 510(K)
- K896891LEUKOSILK(TM) SURGICAL TAPE1Cleared 510(K)
- K896733VACCON1Cleared 510(K)
- K896358VARI/MOIST WOUND DRESSING1Cleared 510(K)
- K895884BANDAGE REMOVAL STRIP1Cleared 510(K)
- K895408OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)1Cleared 510(K)
- K894367LEUKOSPORT(TM) ADHESIVE TAPE1Cleared 510(K)
- K892450MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS1Cleared 510(K)
- K895353OPSITE I.V. 30001Cleared 510(K)
- K894916COMFEEL TRANSPARENT DRESSING1Cleared 510(K)
- K895376ACTIDERM (TM) DERMATOLOGICAL PATCH1Cleared 510(K)
- K893569QUICK CHANGE MONTGOMERY STRAP1Cleared 510(K)
- K894274EXUSORB TRANSPARENT DRESSING1Cleared 510(K)
- K890917PHOENIX DRAPES WITH MICROBAN1Cleared 510(K)
- K894147VISULIN TRANSPARENT ADHESIVE DRESSING1Cleared 510(K)
- K893900PRIMAPORE I.V.1Cleared 510(K)
- K885205AQUADERM1Cleared 510(K)
- K883660DERMASTRIP1Cleared 510(K)
- K883983SANIFIX1Cleared 510(K)
- K884108MACROPORE MEDICAL/SURGICAL PAPER TAPE1Cleared 510(K)
- K881397SANAPLAST1Cleared 510(K)
- K881509LEUKOPOR(TM) SURGICAL TAPE1Cleared 510(K)
- K880207EXPANDOVER ELASTIC BANDAGE1Cleared 510(K)
- K880964POLYDERM PEC(TM), POROUS ELASTIC COVER1Cleared 510(K)
- K872975LIGHTPLAST(TM)1Cleared 510(K)
- K872593ANDOVER ADHESIVE TAPE, SURGICAL1Cleared 510(K)
- K872594ANDOVER MOLESKIN1Cleared 510(K)
- K870900THE GRIPPER SEAL(TM)1Cleared 510(K)
- K870092MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM1Cleared 510(K)
- K870093MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM1Cleared 510(K)
- K870021MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE1Cleared 510(K)
- K870091IV SECUREMENT DEVICE USING PCCE THERMO. FILM1Cleared 510(K)
- K870090IV SECUREMENT DEVICE USING HYTREL THERMO. FILM1Cleared 510(K)
- K870020IV SECUREMENT DEVICE1Cleared 510(K)
- K864076HERCON ANTISEPTIC TRANSPARENT DRESSING1Cleared 510(K)
- K864160LEUKOPLAST(R) POROUS AND SPORT TAPE1Cleared 510(K)
- K863753FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 30001Cleared 510(K)
- K860804MEDICAL ADHESIVE TAPE1Cleared 510(K)
- K854006PLASTELAST AND/OR ELASTOPLASTE1Cleared 510(K)
- K853820SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE1Cleared 510(K)
- K853644NITTO SURGICAL PLASTIC TAPE ST-3561Cleared 510(K)
- K853647NITTO SURGICAL PAPER TAPE ST-3101Cleared 510(K)
- K853646NITTO SURGICAL NON-WOVEN TAPE ST-3201Cleared 510(K)
- K853645NITTO SURGICAL CLOTH TAPE ST-3301Cleared 510(K)
- K852408EXTRA LARGE ADHESIVE STRIPS1Cleared 510(K)
- K852462TRICOT ADHESIVE BANDAGE1Cleared 510(K)
- K850529SHEER ADHESIVE BANDAGES, STERILE1Cleared 510(K)
- K850133VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.1Cleared 510(K)
- K843873LEUKOFIX R1Cleared 510(K)
- K843876LEUKOFLEX SURGICAL TAPE1Cleared 510(K)
- K843875LEUKOSILK1Cleared 510(K)
- K843874LEUKOPOR SURGICAL TAPE1Cleared 510(K)
- K844463DERMIDRESS1Cleared 510(K)
- K842946ACU-PATCH1Cleared 510(K)
- K843587PETIT BANDS1Cleared 510(K)
- K842511BAND-AID BRAND ADHESIVE BANDAGE-MEDICA1Cleared 510(K)
- K842301DISPOSABLE LATEX BANDAGE1Cleared 510(K)
- K840950ZINC OXIDE TAPE1Cleared 510(K)
- K840951FIRST AID BANDAGE1Cleared 510(K)
- K840609SKIN TECH. ISOTEX 86L1Cleared 510(K)
- K840446MEDICAL TAPE1Cleared 510(K)
- K840448MEDICAL ADHESIVE FOAM TAPE1Cleared 510(K)
- K840949CLEAR PLASTIC-HYPOALLERGENIC1Cleared 510(K)
- K840947CLOTH-HYPOALLERGENIC1Cleared 510(K)
- K840447MICROPOROUS MED. ADHESIVE TAPE1Cleared 510(K)
- K841899FIRST RESPONSE EMERG. MEDICAL SYS BONES1Cleared 510(K)
- K841897FIRST RESPONSE EMERG. MEDICAL SYSTEM1Cleared 510(K)
- K833688SUTURE REMOVAL KITS STERILE1Cleared 510(K)
- K833954MELOLITE1Cleared 510(K)
- K833916HYPAFIX DRESSING RETENTION SHEET1Cleared 510(K)
- K833731BREATHABLE OVERWRAY BANDAGE NON-ELAS1Cleared 510(K)
- K833590DRESS, SURGICAL ADHESIVE1Cleared 510(K)
- K833120ONE TIME COMPOUND BENZOIN TINCTURE-1Cleared 510(K)
- K832544SYSTENET1Cleared 510(K)
- K822824ADHESIVE TAPE/FIRST-BAND1Cleared 510(K)
- K8132653M STERI-STRIP ANTIMICROBIAL SKIN CLOS1Cleared 510(K)
- K823076SATOBAN FIRST AID TAPE1Cleared 510(K)
- K821490SILKAFIX ADHESIVE PLASTER1Cleared 510(K)
- K821257SELOFIX1Cleared 510(K)
- K820872CURITY SHETHOSCOPE SECURING PADS1Cleared 510(K)
- K820018COMFEEL PROTECTIVE SHEET1Cleared 510(K)
- K813364MEDICAL TAPE (MULTIPLE)1Cleared 510(K)
- K813361ADHESIVE STRIP(MULTIPLE)1Cleared 510(K)
- K813421NON-ADHER PADS1Cleared 510(K)
- K813124ETHICON* SKIN CLOSURE TAPE1Cleared 510(K)
- K811291TEGADERM TRANSPARENT DRESSING1Cleared 510(K)
- K810896VENTI-GARD JR.1Cleared 510(K)
- K810623BAND-AID KITCHEN ASSORTMENT1Cleared 510(K)
- K810580SCOTCH BRAND ADHESIVE TAPE1Cleared 510(K)
- K810126CURITY CURAD BANDAGES1Cleared 510(K)
- K810053JOHNSON & JOHNSON ADHESIVE FILM DRESSING1Cleared 510(K)
- K803153ELASTIC ADHESIVE BANDAGES1Cleared 510(K)
- K802795ORTHOPEDIC PADDING1Cleared 510(K)
- K802752POROUS, BREATHING TAPE W/RELEASE LINER1Cleared 510(K)
- K802764PLASTIC ADHESIVE BANDAGE1Cleared 510(K)
- K8022423M HI-STRENGTH MED. TAPE #15341Cleared 510(K)
- K802073MUELLER STRETCH M TAPE1Cleared 510(K)
- K801794ELASTIC ADHESIVE BANDAGES(STERILE)1Cleared 510(K)
- K800907TOMAC WET DRESSING WARMER1Cleared 510(K)
- K792666LEUKOPOR1Cleared 510(K)
- K792103HYPO-ALLERGENIC PAPER ADHESIVE TAPE1Cleared 510(K)
- K792102HYPO-ALLERGENIC CLOTH ADHESIVE TAPE1Cleared 510(K)
- K791886I.V. CARE KIT1Cleared 510(K)
- K791885I.V. START SET1Cleared 510(K)
- K791288YELLOW ALERT SYSTEM1Cleared 510(K)
- K770362TAPE, DERMICEL, CLOTH1Cleared 510(K)
- K761336BAND-AID BRAND PLASTIC BANDAGES1Cleared 510(K)
- K761335BAND-AID BRAND SHEER BANDAGES1Cleared 510(K)
- KMFBandage, Liquid1Product Code
- LRSI.V. Start Kit2Product Code
- MCYWound Dressing Kit2Product Code
- MHWDressing, Compression1Product Code
- NECBandage, Liquid, Skin Protectant1Product Code
- OXQDressing Change Tray1Product Code
- PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use1Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HYPAFIX DRESSING RETENTION SHEET
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K833916
- 510(k) Type
- Traditional
- Applicant
- SMITH & NEPHEW, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/12/1984
- Days to Decision
- 119 days