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
- KMFBandage, Liquid1Product Code
- K241916TearRepair Liquid Skin Protectant1Cleared 510(K)
- K182733Rochal Bioshield Silicone Film1Cleared 510(K)
- K171148Aleo BME Liquid Bandage1Cleared 510(K)
- K153571Cavilon Advanced High Endurance Skin Protectant1Cleared 510(K)
- K160684Atteris No-Sting Skin Protectant1Cleared 510(K)
- K131384KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE1Cleared 510(K)
- K133443MARATHON NO STING LIQUID SKIN PROTECTANT1Cleared 510(K)
- K120059LIQUID BANDAGE1Cleared 510(K)
- K092712SKIN BARRIER FILM1Cleared 510(K)
- K083087ECOCEL1Cleared 510(K)
- K083913CHESSON LABS LIQUID BANDAGE1Cleared 510(K)
- K083752GLUSEAL 90, MODEL GLU90101Cleared 510(K)
- K082703MRDH BANDAGE1Cleared 510(K)
- K081009NEUTROPHASE1Cleared 510(K)
- K073663GELSPRAY WOUND DRESSING1Cleared 510(K)
- K063202PRODERMA LIQUID BANDAGE1Cleared 510(K)
- K984207SILVERLON DIRECT PRESSURE WOUND DRESSING1Cleared 510(K)
- K062602BAND-AID(R) BRAND LIQUID BANDAGE1Cleared 510(K)
- K0534093M LIQUID BANDAGE1Cleared 510(K)
- K042955CUTICOVER SKIN BARRIER DEVICE1Cleared 510(K)
- K050757FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE1Cleared 510(K)
- K051082MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)1Cleared 510(K)
- K032948ELASTIC SKIN LIQUID BANDAGE1Cleared 510(K)
- K040779RESTORE WOUND CLEANSER1Cleared 510(K)
- K031321LIQUISHIELD LIQUID BANDAGE, MODEL LSB 00011Cleared 510(K)
- K0312633M LIQUID BANDAGE, MODEL 120-LB1Cleared 510(K)
- K030574GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER1Cleared 510(K)
- K023163LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 00201Cleared 510(K)
- K022645CURAD1Cleared 510(K)
- K013225INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE1Cleared 510(K)
- K002338LIQUIDERM LIQUID ADHESIVE BANDAGE1Cleared 510(K)
- K002550RDH BANDAGE1Cleared 510(K)
- K991729FERRIS POLYOSTOMY STERILE WOUND DRESSING1Cleared 510(K)
- K992032ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 20331Cleared 510(K)
- K991920DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING1Cleared 510(K)
- K991933DERMAPHYLYX FOAM ISLAND DRESSING1Cleared 510(K)
- K991609DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING1Cleared 510(K)
- K991608DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING1Cleared 510(K)
- K991694DYNAREX DRAIN SPONGE1Cleared 510(K)
- K991695DYNAREX NON-WOVEN SPONGE1Cleared 510(K)
- K990955MODIFICATION OF:BIODERM FOAM WOUND DRESSING1Cleared 510(K)
- K990906FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER1Cleared 510(K)
- K984539FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING1Cleared 510(K)
- K973227ASKINA HYDROCOLLOID/THIN1Cleared 510(K)
- K983519COMFEEL SEASORB DRESSING1Cleared 510(K)
- K984177MODIFICATION TO SKVEKPATCH1Cleared 510(K)
- K980117NUVO BARRIER FILM1Cleared 510(K)
- K983833ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE1Cleared 510(K)
- K983210ALGISITE M1Cleared 510(K)
- K983554ALLDRESS, ABSORBENT FILM DRESSING1Cleared 510(K)
- K9828933M TEGASORB HYDROCOLLOID DRESSING1Cleared 510(K)
- K9828923M TEGASORB THIN HYDROCOLLOID DRESSING1Cleared 510(K)
- K982818HOSPAL TIPSTOP1Cleared 510(K)
- K982778BIODERM FOAM WOUND DRESSING1Cleared 510(K)
- K982234AL-GEN CALCIUM ALGINATE DRESSING1Cleared 510(K)
- K982116AQUACEL HYDROFIBER WOUND DRESSING1Cleared 510(K)
- K980779THALAFIX NATURAL SEA SALT DRESSING1Cleared 510(K)
- K9809893M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING1Cleared 510(K)
- K980673SPYROSORB FOAM ISLAND WOUND DRESSING1Cleared 510(K)
- K980863DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)1Cleared 510(K)
- K980720NONWOVEN PAD1Cleared 510(K)
- K980451BIODERM CALCIUM ALGINATE DRESSING1Cleared 510(K)
- K971612OSMO/PCA PILLOW WOUND DRESSING1Cleared 510(K)
- K980382NON-WOVEN COMPRESS1Cleared 510(K)
- K974823NONWOVEN DRESSING1Cleared 510(K)
- K974205KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON1Cleared 510(K)
- K973619KENDALL CURITY NON-ADHERING DRESSING1Cleared 510(K)
- K972329OSMOCYTE RA WOUND DRESSING1Cleared 510(K)
- K972150OSMOCYTE ISLAND WOUND DRESSING1Cleared 510(K)
- K973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1Cleared 510(K)
- K973429BIODERM FOAM WOUND DRESSING1Cleared 510(K)
- K973228STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)1Cleared 510(K)
- K973283ALGINATE/ZINC WOUND DRESSING1Cleared 510(K)
- K972530CONVATEC ODOR CONTROL WOUND DRESSING1Cleared 510(K)
- K971091OPPURTUNITY TRACHEOSTOMY CARE KIT1Cleared 510(K)
- K971090OPPORTUNITY DRESSING CHANGE TRAY1Cleared 510(K)
- K972062CONVATEC NON-ADHESIVE DRESSING1Cleared 510(K)
- K970660DERMAGRAN WOUND MANAGEMENT SYSTEM1Cleared 510(K)
- K972336DERMAMEND HYDROGEL GAUZE DRESSING1Cleared 510(K)
- K971337EPITECH ISLAND DRESSINGS1Cleared 510(K)
- K970600DERMAMEND FOAM ISLAND DRESSING1Cleared 510(K)
- K965120ALLCLENZ WOUND CLEANSER1Cleared 510(K)
- K964231NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)1Cleared 510(K)
- K964614ULTRAFERA WOUND DRESSING1Cleared 510(K)
- K964016TIELLE HYDROPOLYMER FOAM DRESSING1Cleared 510(K)
- K963603DERMAGRAN HYDROPHILIC OINTMENT1Cleared 510(K)
- K963598INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS1Cleared 510(K)
- K962623OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING1Cleared 510(K)
- K963656FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING1Cleared 510(K)
- K963602BIODERM PVP FOAM WOUND DRESSING1Cleared 510(K)
- K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING1Cleared 510(K)
- K954728PROD NO. 01-1694 - 4X4 FOAM DRESSING1Cleared 510(K)
- K962740DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/2606411Cleared 510(K)
- K962421SORBCEL ALGINATE/CMC WOUND DRESSING1Cleared 510(K)
- K961323LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING1Cleared 510(K)
- K961662ADVANCED CARE HYDROPHILIC WOUND DRESSINGS1Cleared 510(K)
- K961452LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING1Cleared 510(K)
- K955453ACTICOAT SILVER COATED DRESSING1Cleared 510(K)
- K955399MULTIDEX PLUS HYDROPHILIC WOUND DRESSING1Cleared 510(K)
- K9551033M NO STING BARRIER FILM1Cleared 510(K)
- K953500HEMO-BARRIER1Cleared 510(K)
- K954275MEPORE PLUS (9X15CM)1Cleared 510(K)
- K954918COMBIDERM ACD1Cleared 510(K)
- K950621BIOFILL BIOCELLULOSE DRESSING STERILE1Cleared 510(K)
- K954274MEPORE (6X7)1Cleared 510(K)
- K954919MEROCEL SOFT WOUND DRESSING1Cleared 510(K)
- K954857COMFEEL:ALGINATE FILLER1Cleared 510(K)
- K952565LYOFOAM EXTRA1Cleared 510(K)
- K954230SORBSAN PLUS TOPICAL WOUND DRESSING1Cleared 510(K)
- K953403DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS1Cleared 510(K)
- K953497COMFEEL:ALGINATE DRESSING1Cleared 510(K)
- K953019HYDROPHILIC FOAM DRESSING1Cleared 510(K)
- K953131EXUSORB STERILE ABSORBENT1Cleared 510(K)
- K953070WOUNDFOAM 4 X 41Cleared 510(K)
- K953781INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS1Cleared 510(K)
- K951561DYNASORB1Cleared 510(K)
- K952547COVERSAN, ISLESAN1Cleared 510(K)
- K952526CUTINOVA CAVITY1Cleared 510(K)
- K952420STERIGAUZE WET DRESSING1Cleared 510(K)
- K951909RYNEL MEDICAL FOAM1Cleared 510(K)
- K951730SPYROFOAM WOUND DRESSING1Cleared 510(K)
- K950685BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING1Cleared 510(K)
- K951914HYDRACARE ABSORBENT WOUND DRESSING1Cleared 510(K)
- K951327COMFEEL PLUS CONTOUR DRESSING1Cleared 510(K)
- K950619BIODERM MEDICAL FOAM WOUND DRESSING1Cleared 510(K)
- K951499DERMAGRAN HYDROPHILIC OINTMENT1Cleared 510(K)
- K946245TIELLE* HYDROPOLYMER DRESSING1Cleared 510(K)
- K950775CURASORB ZN ALGINATE WOUND DRESSING1Cleared 510(K)
- K945224GRX FOAM DRESSING1Cleared 510(K)
- K945802DERMAGRAN WOUND CLEANSER WITH ZINC1Cleared 510(K)
- K945330ALLEVYN ADHESIVE1Cleared 510(K)
- K946269CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS1Cleared 510(K)
- K945206ALLDRESS MULTI LAYERED WOUND DRESSING1Cleared 510(K)
- K944581CUTINOVA THIN WOUND DRESSING1Cleared 510(K)
- K944468KERLIX ZINC SALINE DRESSING1Cleared 510(K)
- K944491DERMAGRAN HYDROPHILIC OINTMENT1Cleared 510(K)
- K945000MULTIDEX HYDROPHILIC WOUND DRESSING1Cleared 510(K)
- K943781ACRYDERM ADVANCED WOUND DRESSING1Cleared 510(K)
- K943636CURADERM ALGINATE HYDROCOLLOID1Cleared 510(K)
- K941688INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS1Cleared 510(K)
- K943619CAVI-CARE CONFORMING FOAM DRESSING1Cleared 510(K)
- K943258HYDROCOLLOID WOUND DRESSING1Cleared 510(K)
- K942270SAF-GEL HYDRATING DERMAL WOUND DRESSING1Cleared 510(K)
- K943364CORASSIST WOUND DRESSING1Cleared 510(K)
- K942283COMFEEL PLUS TRANSPARENT DRESSING1Cleared 510(K)
- K941176ALGINATE FIBER1Cleared 510(K)
- K942815HYDROSKIN WOUND DRESSING1Cleared 510(K)
- K941999HYPERTONIC SALINE WET DRESSING - STERILE1Cleared 510(K)
- K942459CURASALT HYPERTONIC SALINE DRESSING1Cleared 510(K)
- K940572MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)1Cleared 510(K)
- K932913FERRIS POLYMEM HYDROPHILIC WOUND DRESSING1Cleared 510(K)
- K941216HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING1Cleared 510(K)
- K941263COMFEEL PLUS WOUND DRESSING1Cleared 510(K)
- K940738KTI HY-Q(TM) WOUND DRESSING1Cleared 510(K)
- K9406243M TEGASORB HYDROCOLLOID DRESSING1Cleared 510(K)
- K940404ALGINATE FIBER TOPICAL WOUND DRESSING1Cleared 510(K)
- K940414IODOFLEX PASTE1Cleared 510(K)
- K940407KALTOGEL WOUND DRESSING1Cleared 510(K)
- K936193COMB-18 WOUND DRESSING1Cleared 510(K)
- K936052BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING1Cleared 510(K)
- K935783MITRAFLEX CAVITY WOUND DRESSING1Cleared 510(K)
- K923516COMPOUND BENZOIN TINCTURE USP SEPP1Cleared 510(K)
- K920399COMPOUND BENZOIN TINCTURE USP FREPP1Cleared 510(K)
- K923299APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK1Cleared 510(K)
- K925004ALLKARE BARRIER WIPE1Cleared 510(K)
- K935060BRENNEN MEDICAL STERILE SALINE SOLUTION1Cleared 510(K)
- K926230EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN1Cleared 510(K)
- K934839MESALT STERILE DRESSING1Cleared 510(K)
- K930632CHEMOSITE IMPLANTABLE DRUG DELIVERY1Cleared 510(K)
- K933689MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING1Cleared 510(K)
- K925993DUODERM HYDROACTIVE DRESSING1Cleared 510(K)
- K925991DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER1Cleared 510(K)
- K925990DUODERM EXTRA THIN CGF DRESSING1Cleared 510(K)
- K925937WELLS LAMONT HANDAGES/MED WRAP DRESSINGS1Cleared 510(K)
- K931565MEROCEL WOUND DRESSING1Cleared 510(K)
- K9304683M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X1Cleared 510(K)
- K926380ALTA DRESSING FRAME1Cleared 510(K)
- K9242803M TEGASORB THIN HYDROCOLLOID DRESSING1Cleared 510(K)
- K923957NASAL CAVITY WOUND DRESSING1Cleared 510(K)
- K926044MPM WET DRESSING (SALINE)1Cleared 510(K)
- K925376COMFEEL(R) WOUND DRESSING SD1Cleared 510(K)
- K925001CURITY CALCIUM ALGINATE WOUND DRESSING1Cleared 510(K)
- K922760ATRAUM WOUND DRESSING--MODIFICATION1Cleared 510(K)
- K921502HYSORB WOUND DRESSING1Cleared 510(K)
- K922681CUTINOVA FOAM1Cleared 510(K)
- K922540WOUND DRESSING1Cleared 510(K)
- K922466COMFEEL WOUND DRESSING SD1Cleared 510(K)
- K922461COMFEEL WOUND DRESSING ORD1Cleared 510(K)
- K920794BRND SKIN PROTECTION PREP SERIES 33XX1Cleared 510(K)
- K921009KALTOSTAT FORTEX WOUND DRESSING1Cleared 510(K)
- K920925COMFEEL CONTOUR DRESSING1Cleared 510(K)
- K920366ULCUFLEX HYDROCOLOID POWDER1Cleared 510(K)
- K920368ULCUFLEX HYDROCOLLOID PASTE1Cleared 510(K)
- K920367ULCUFLEX HYDROCULLOID DRESSING1Cleared 510(K)
- K912506CRITIC-AID WOUND DRESSING1Cleared 510(K)
- K914147ALLEVLYN WOUND DRESSING, MODIFICATION1Cleared 510(K)
- K914314FORTEX(TM) WOUND DRESSING1Cleared 510(K)
- K910927SPENCIO SKIN GUARD KIT1Cleared 510(K)
- K905439HYPERGEL PROTECTIVE WOUND GEL1Cleared 510(K)
- K904411INTRASITE GEL (LABELING REVISION)1Cleared 510(K)
- K895764MODIFIED LYOFOAM WOUND DRESSINGS1Cleared 510(K)
- K901877ALLEVYN DRESSING (LABELING REVISED)1Cleared 510(K)
- K901878INTRASITE GEL (LABELING REVISION)1Cleared 510(K)
- K900127FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)1Cleared 510(K)
- K901155DUODERM* CONTROL GEL FORMULA BORDER DRESSING1Cleared 510(K)
- K896531NOVADERM1Cleared 510(K)
- K895819MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL1Cleared 510(K)
- K895606EXUSORB(TM) GEL DRESSING1Cleared 510(K)
- K864124SPAND-GEL GRANULATED GEL1Cleared 510(K)
- K843300SKIN-LITE1Cleared 510(K)
- K820134VIGILON PRIMARY WOUND DRESSING, STERILE1Cleared 510(K)
- K811625PREP-SITE PROTECTIVE DRESSING WIPE1Cleared 510(K)
- K811446HYDRON WOUND DRESSING KIT1Cleared 510(K)
- K810240CLINIGUARD STERILE1Cleared 510(K)
- K800527CLINIGUARD1Cleared 510(K)
- K791865HYDRON BURN DRESSING FIELD KIT1Cleared 510(K)
- K782008DRESSING, ENVIRON WOUND1Cleared 510(K)
- K790384KIMLON BEDGARD UNDERPAD1Cleared 510(K)
- K781877UNDERPADS, HIGH ABSORBANT POLYMER1Cleared 510(K)
- K781406HYDRON BURN BANDAGE MANUAL APPLICATION1Cleared 510(K)
- K781031AEROPLAST DRESSING1Cleared 510(K)
- K780616HYDRON BURN DISPOSABLE DISPENSER SET1Cleared 510(K)
- K771321HYDRON BURN BANDAGE1Cleared 510(K)
- 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
INTRASITE GEL (LABELING REVISION)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K904411
- 510(k) Type
- Traditional
- Applicant
- SMITH & NEPHEW UNITED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 11/26/1990
- Days to Decision
- 61 days