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
- MVFSystem, Laser, Photodynamic Therapy3Product Code
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy3Product Code
- MWZExpander, Breast, ExternalUProduct Code
- MYHSystem, Non-Coherent Light, Photodynamic Therapy3Product Code
- NBESealant, Polymerizing3Product Code
- PBDComposite Cultured SkinFProduct Code
- QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions2Product Code
- MTJWax, BoneUProduct Code
- DTHSuture, Cardiovascular3Product Code
- DZGSuture, Dental3Product Code
- EFQGauze/Sponge, InternalUProduct Code
- EYFProtector, Wound, PlasticUProduct Code
- FRODressing, Wound, DrugUProduct Code
- GELGauze/Sponge, Internal, With Drug/Biologic, Animal Source MaterialUProduct Code
- GERGauze, External (With Drug/Biologic/Animal Source Material)UProduct Code
- K940755ISOLYER (4X4, 8PLY)UCleared 510(K)
- K934258SALINE WET DRESSING- STERILEUCleared 510(K)
- K933774IMC SALINE WET DRESSINGUCleared 510(K)
- K933966SURE-ADAPT NON-ADHERING DRESSINGUCleared 510(K)
- K931510GERITREX STERILE SALINE WET DRESSINGUCleared 510(K)
- K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONUCleared 510(K)
- K924754DERMAGRAN WOUND DRESSINGUCleared 510(K)
- K926207MEDTRAX PACKING STRIPUCleared 510(K)
- K925841HYDRASORB JOYCE SPONGEUCleared 510(K)
- K925590MULTI-TRAUMA DRESSINGUCleared 510(K)
- K924650GAUZE SPONGESUCleared 510(K)
- K923602ABSORBENT PAD -- MODIFICATIONUCleared 510(K)
- K923115CLINISORBUCleared 510(K)
- K922729SPARTA WET DRESSING, SODIUM CHLORIDEUCleared 510(K)
- K921290INMAN MEDICAL OIL EMULSION DRESSINGUCleared 510(K)
- K921289INMAN MEDICAL PETROLATUM DRESSINGUCleared 510(K)
- K923116COMBINE II WETPROOF PADUCleared 510(K)
- K923846BURN DRESSINGUCleared 510(K)
- K920355SPECIALTY SPONGESUCleared 510(K)
- K921227TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGEUCleared 510(K)
- K920282PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLEUCleared 510(K)
- K915821MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZESUCleared 510(K)
- K920269EZ GAUZE SPONGEUCleared 510(K)
- K915822MULTIPLE DRESSING, STERILE NONADDHERENT PADSUCleared 510(K)
- K914604MEPITEL NON-ADHERENT SILICONE DRESSINGUCleared 510(K)
- K914937STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHESUCleared 510(K)
- K914842GAUZE BANDAGE ROLLUCleared 510(K)
- K914779ALGINATE FIBERUCleared 510(K)
- K914575SORBSAN TOPICAL WOUND DRESSING (MODIFIED)UCleared 510(K)
- K914431ABSORBENT FIBERUCleared 510(K)
- K914071MULTIPLE BURN DRESSINGUCleared 510(K)
- K913779BANDAGE ROLL, GAUZEUCleared 510(K)
- K912950COMPRESS DRESSINGUCleared 510(K)
- K912952BANDAGE COMPRESSUCleared 510(K)
- K912693POST OPERATIVE SPONGEUCleared 510(K)
- K912692CONFORMING BANDAGEUCleared 510(K)
- K912953GAUZE COMPRESSUCleared 510(K)
- K912779GAUZE SPONGE,STERILE 2'SUCleared 510(K)
- K913035INCARE HOT/ICE ABSORBENT INTERFACEUCleared 510(K)
- K91295112-PLY GAUZE PADUCleared 510(K)
- K912954STRETCH GAUZE BANDAGEUCleared 510(K)
- K913575GAUZE PACKING, SURGICAL STERILE AND NON-STERILEUCleared 510(K)
- K912949TRIANGULAR BANDAGE,40UCleared 510(K)
- K912104MAJOR BASIN TRAYUCleared 510(K)
- K912022FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZESUCleared 510(K)
- K910857ALLDRESS MULTI LAYERED WOUND DRESSINGUCleared 510(K)
- K901564SOLUSPONGE - S-99UCleared 510(K)
- K900691BIODYNE INSTRUMENT WIPESUCleared 510(K)
- K891324HERMITEX SPONGEUCleared 510(K)
- K891101NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSINGUCleared 510(K)
- K885045PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSHUCleared 510(K)
- K8702824 X 4 SPONGES, NON-STERILEUCleared 510(K)
- K8702833 X 3 SPONGES, NON-STERILEUCleared 510(K)
- K854344AQUACEL SURGICAL PREP PADSUCleared 510(K)
- K843035SANG-A PETROLATUM GAUZE USP STERILEUCleared 510(K)
- K840541NEURO SPONGEUCleared 510(K)
- K833626FLORET FOAM PREP SPONGEUCleared 510(K)
- K831284GAUZE BANDAGEUCleared 510(K)
- K831282BANDAGE COMPRESSUCleared 510(K)
- K831281GAUZE COMPRESSUCleared 510(K)
- K830473NOVA GAUZEUCleared 510(K)
- K830263FLORET NASAL TAMPONUCleared 510(K)
- K822987DRESSING SPONGEUCleared 510(K)
- K822966CONVERTORS DISPOSABLE DRESSING SPONGEUCleared 510(K)
- K820095TONSIL SPONGESUCleared 510(K)
- K820053KERLIX FLUFFSUCleared 510(K)
- K810655DISPOSABLE SCRUB BRUSHUCleared 510(K)
- K803116HEAVY DRAINAGE PACKUCleared 510(K)
- K802798OPRATEX ABDOMINAL PADUCleared 510(K)
- K802004PROFILE SWAB CAT.#5273 & 5274UCleared 510(K)
- K800058ANAGO ELECTRO SURGICAL TIP CLEANERUCleared 510(K)
- K792272DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLOUCleared 510(K)
- K792271DEXIDE DISPOSABLE SURGICAL SCRUB SPONGEUCleared 510(K)
- K792273DEXIDE DIS. PREP SPONGE W/IDEX PATIENT PUCleared 510(K)
- K792242SURGI-PREP PAINT STICK #1 WET PACKUCleared 510(K)
- K791950DEXIDE DISPOSABLE SURGICAL SCRUB SPONGEUCleared 510(K)
- K791951DEXIDE DISPOSABLE SURGICAL SCRUB SPONGEUCleared 510(K)
- K791736MEROCEL INSTRUMENT WIPEUCleared 510(K)
- K782107LAP SPONGEUCleared 510(K)
- K770410BANDAGE COMPRESS 2, 3, 4UCleared 510(K)
- HMNSuture, Nonabsorable, Ophthalmic3Product Code
- HMOSuture, Absorbable, Ophthalmic3Product Code
- KGMSilicone, Liquid, Injectable3Product Code
- KGNDressing, Wound, CollagenUProduct Code
- LCJExpander, Skin, InflatableUProduct Code
- LFLInstrument, Ultrasonic SurgicalUProduct Code
- LMHImplant, Dermal, For Aesthetic Use3Product Code
- LMIImplant, Collagen For Non-Aesthetic Use3Product Code
- LRQTracheostomy And Nasal Suctioning Kit1Product Code
- LRRFirst Aid Kit With DrugNProduct Code
- LXULaser For Wound Healing3Product Code
- MAWMarker, Suture IdentificationUProduct Code
- MDDDevice, Dermal Replacement3Product Code
- MGPDressing, Wound And Burn, OcclusiveUProduct Code
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUProduct Code
- MGRDressing, Wound And Burn, Interactive3Product Code
- MQZProsthesis, NailUProduct Code
- MRDSizer, Mammary, Breast Implant VolumeUProduct Code
- MSADressing, Wound And Burn, Occlusive, HeatedUProduct Code
- NLQScalpel, Ultrasonic, ReprocessedUProduct Code
- NQKMaggots, MedicalUProduct Code
- NRNLeeches, MedicinalUProduct Code
- NSSElectronic Media, NauseaNProduct Code
- NZFStatic Electricity-Emitting Device, Cosmetic UseNProduct Code
- OCECultured Epithelial AutograftFProduct Code
- ODSWound Covering (Composite Cultured Skin)FProduct Code
- OEEDiagnostic Low Electric Field3Product Code
- OJIBurn Kit With DrugNProduct Code
- ONVElectrical Impedance Spectrometer3Product Code
- OYDOptical Diagnostic Device For Melanoma Detection3Product Code
- PFCCultured Human Cell Skin Dressing3Product Code
- PHUIntra-Abdominal Pressure Monitoring DeviceUProduct Code
- PKYImplant, Dermal, For Aesthetic Use In The Hands3Product Code
- PUVLymph Node Location System During Sentinel Biopsy Procedure3Product Code
- PZCAblation System, High Intensity Focus Ultrasound (Hifu), Soft TissueNProduct Code
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)NProduct Code
- QQFSkin Microneedling Manual/Automated Device (Export Only)NProduct Code
- QVSBreast Implant Suction Retrieval Device2Product Code
- QVXSkin Patch For Treatment Of Hyperhidrosis2Product Code
- PLJTissue Adhesive Internal Use3Product Code
- QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUProduct Code
- QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUProduct Code
- QSZAbsorbable Synthetic Wound DressingUProduct Code
- QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation2Product Code
- QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer2Product Code
- SABTable Mounted Miniaturized Electromechanical Surgical System2Product Code
- SAQElectromechanical System For Open Microsurgery2Product Code
- SAWFluorescence Imaging For Breast Cancer Detection3Product Code
- QMLAnal Fistula Closure Device2Product Code
- SAHMagnetic Compression Anastomosis System2Product Code
- QYKSemi-Automated Autologous Skin Graft Harvesting And Application Device2Product Code
- SCVModular Electromechanical Surgical System2Product Code
- SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field2Product Code
- SEJWound Dressings Containing Topical AnalgesicsUProduct Code
- SEKWound Dressings With HydrocortisoneUProduct Code
- SELSecurement Wound Dressing For Reduction Of InfectionUProduct Code
- QXWCryoablation Device For Local Treatment Of Low-Risk Breast Cancer2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K921227
- 510(k) Type
- Traditional
- Applicant
- COURTAULDS FIBERS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/29/1992
- Days to Decision
- 77 days
- Submission Type
- Summary