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
- 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
- K012997COLLATEK FOAMUCleared 510(K)
- K012995COLLATEK SHEETUCleared 510(K)
- K001508LASERSKIN DRESSINGUCleared 510(K)
- K990079FASTSEAL CHEST WOUND DRESSINGUCleared 510(K)
- K991214SIMPLICARE TRANSPARENT WOUND DRESSINGUCleared 510(K)
- K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSUCleared 510(K)
- K992005GILTECH PLUS TRANSPARENT DRESSINGUCleared 510(K)
- K990875DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSINGUCleared 510(K)
- K990438DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSINGUCleared 510(K)
- K984371MEPITEL NON ADHERENT SILICONE DRESSINGUCleared 510(K)
- K983303INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGSUCleared 510(K)
- K983234TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSINGUCleared 510(K)
- K983394MODIFICATION TO TIELLE HYDROPOLMER DRESSINGUCleared 510(K)
- K983184MEPILEXUCleared 510(K)
- K974891ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013UCleared 510(K)
- K982939BTF THIN FILM WOUND DRESSINGUCleared 510(K)
- K974890ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002UCleared 510(K)
- K974892ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012UCleared 510(K)
- K981713CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0UCleared 510(K)
- K981753INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSINGUCleared 510(K)
- K980209SIMPLICARE THIN FILM WOUND DRESSINGSUCleared 510(K)
- K974520SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAMUCleared 510(K)
- K973538N-TERFACEUCleared 510(K)
- K973657ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSINGUCleared 510(K)
- K9730363M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRESUCleared 510(K)
- K964398SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTEDUCleared 510(K)
- K973312TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSINGUCleared 510(K)
- K973260HYDRASORB STERILE DRESSINGUCleared 510(K)
- K972458LYOCELL WOUND DRESSING/SURGICAL SPONGEUCleared 510(K)
- K971093OPPORTUNITY I.V. START KITUCleared 510(K)
- K970518ALGOPLAQUE HYDROCOLLOID DRESSINGUCleared 510(K)
- K963753NASP TRANSPARENT DRESSINGUCleared 510(K)
- K963623SPYROFLEX PIGMENTED WOUND DRESSINGUCleared 510(K)
- K961319EPIVIEWUCleared 510(K)
- K961098BIO-DRESSING, STERILE ISLAND DRESSINGUCleared 510(K)
- K960847DERMASEALUCleared 510(K)
- K960393SURESKIN BORDERUCleared 510(K)
- K960404SURESKIN THINUCleared 510(K)
- K960394SURESKIN STANDARDUCleared 510(K)
- K955476DUKAL TRANSPARENT WOUND DRESSINGUCleared 510(K)
- K955383SPYROCOLLOID WOUND DRESSINGUCleared 510(K)
- K954243TECNOL SALINE WET DRESSINGUCleared 510(K)
- K953885SPYROFLEX SKIN PROTECTORUCleared 510(K)
- K954742DERMAGRAN WET DRESSING (ZINC-SALINE)UCleared 510(K)
- K954740DERMAGRAN WOUND DRESSINGUCleared 510(K)
- K954739DERMAGRAN HYDROPHILIC OINTMENTUCleared 510(K)
- K954738DERMAGRAN HYDROPHILIC WOUND DRESSINGUCleared 510(K)
- K954743DERMAGRAN WOUND DRESSING CLEANER W/ZINCUCleared 510(K)
- K954602FLEXZAN WOUND DRESSINGUCleared 510(K)
- K954621RECLOSABLE WOUND COVERUCleared 510(K)
- K954235HOLLISTER HYDROCOLLOID WOUND DRESSINGUCleared 510(K)
- K954033TECNOL ISLAND WOUND DRESSINGUCleared 510(K)
- K953018UNI-SITEUCleared 510(K)
- K953618SPYROFLEX WOUND DRESSINGUCleared 510(K)
- K952948SALINE DRESSINGUCleared 510(K)
- K952907EX-111 WOUND DRESSINGUCleared 510(K)
- K952449TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSINGUCleared 510(K)
- K952504TECNOL TRANSPARENT WOUND DRESSINGUCleared 510(K)
- K950933HOLLISTER HYDROCOLLOID WOUND DRESSINGSUCleared 510(K)
- K952217MITRAFLEX WOUND DRESSING WET-STICKUCleared 510(K)
- K952071ULTEC THIN HYDROCOLLOID DRESSINGUCleared 510(K)
- K951842BIODERM MEDICAL TRANSPARENT FILM DRESSINGUCleared 510(K)
- K946338CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSINGUCleared 510(K)
- K945977CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSINGUCleared 510(K)
- K950065CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONSUCleared 510(K)
- K943363CUTIPLAST STERILUCleared 510(K)
- K950132DUMEX WET DRESSINGSUCleared 510(K)
- K942959KIT PAK WET SALINE DRESSINGUCleared 510(K)
- K945675PREPPIES SKIN BARRIER WIPEUCleared 510(K)
- K946292BIODERM MEDICAL COMPOSITE WOUND DRESSINGUCleared 510(K)
- K931766STERIL-DERM-PLUS TRANSPARENT DRESSINGUCleared 510(K)
- K941789PRO-TECT TRAUMA PAKUCleared 510(K)
- K941790PRO-TECT SAFETY DRESSINGUCleared 510(K)
- K940895EPIVIEWUCleared 510(K)
- K943424CUSH ISLAND DRESSINGUCleared 510(K)
- K943111TRANSPARENT DRESSINGUCleared 510(K)
- K943280PROCEL BURN COVER/PROCEL BURN TREATMENT COVERUCleared 510(K)
- K942757ASHERMAN CHEST BANDAGEUCleared 510(K)
- K942774POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSINGUCleared 510(K)
- K941149DERMAASSIST HYDROCOLLOID DRESSINGUCleared 510(K)
- K941005DERMASSIST(TM) XEROFORM PETROLATUM DRESSINGUCleared 510(K)
- K940691WET DRESSINGUCleared 510(K)
- K940694XEROFORM PETROLATUM DRESSINGUCleared 510(K)
- K940693PETROLATUM DRESSINGUCleared 510(K)
- K940110M-K WET SALINE DRESSINGUCleared 510(K)
- K935796HYDRODERM BREATHABLE TRANSPARENT DRESSINGUCleared 510(K)
- K932676SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)UCleared 510(K)
- K926399CUTIFILM(R) FILMUCleared 510(K)
- K931599HYDRASORB STERILE DRESSINGUCleared 510(K)
- K930401ALUMINUM FOILUCleared 510(K)
- K926034EPI-LOCK WOUND DRESSINGUCleared 510(K)
- K925660KTI TRANSPARENT WOUND DRESSINGUCleared 510(K)
- K924008STERILE FILM WOUND DRESSINGUCleared 510(K)
- K922636HEMO-STATUCleared 510(K)
- K923150SILON TRANSPARENT WOUND DRESSINGSUCleared 510(K)
- K920796DEROYAL TRANSPARENT FILM DRESSIGNUCleared 510(K)
- K920875PROLONGED OCCLUSION DRESSING IUCleared 510(K)
- K920874PROLONGED OCCLUSION DRESSING IIUCleared 510(K)
- K915695PROCEL BURN COVERUCleared 510(K)
- K914579SILVER FOAM WOUND DRESSINGUCleared 510(K)
- K915635CURITY VENTED DRESSING SYSTEMUCleared 510(K)
- K914840DERMAPROOFUCleared 510(K)
- K912032SILON(TM) TRANSPARENT WOUND DRESSINGUCleared 510(K)
- K911649MITRASHEER TRANSPLANT DRESSINGUCleared 510(K)
- K911161INERPAN(TM) TEMPORARY WOUND DRESSINGUCleared 510(K)
- K911660INTRASITE HYDROCOLLOID WOUND DRESSINGUCleared 510(K)
- 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
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
- Page Type
- Cleared 510(K)
- 510(k) Number
- K964398
- 510(k) Type
- Traditional
- Applicant
- POLYMEDICA INDUSTRIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/24/1997
- Days to Decision
- 354 days
- Submission Type
- Summary