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
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- GEJCarrier, Ligature1Product Code
- GENForceps, General & Plastic Surgery1Product Code
- GEOFile, Surgical, General & Plastic Surgery1Product Code
- GESBlade, Scalpel1Product Code
- GETMotor, Surgical Instrument, Pneumatic Powered1Product Code
- GEXPowered Laser Surgical Instrument2Product Code
- GEYMotor, Surgical Instrument, Ac-Powered1Product Code
- GFABlade, Saw, General & Plastic Surgery, Surgical1Product Code
- GFBHead, Surgical, Hammer1Product Code
- GFCDriver, Surgical, Pin1Product Code
- GFDDermatome1Product Code
- GFEBrush, Dermabrasion, Powered1Product Code
- GFFBur, Surgical, General & Plastic Surgery1Product Code
- GFGBit, Surgical1Product Code
- GFIOsteotome, Manual1Product Code
- GFJMallet, Surgical, General & Plastic Surgery1Product Code
- HABSaw, Powered, And Accessories1Product Code
- HAMApparatus, Electrosurgical2Product Code
- HBIIlluminator, Fiberoptic, Surgical Field2Product Code
- HBTApplier, Hemostatic Clip1Product Code
- HCFInstrument, Ligature Passing And Knot Tying1Product Code
- HJELamp, Fluorescein, Ac-Powered2Product Code
- HMPPad, Eye1Product Code
- HRBMicroscope, Operating, Non-Electric, Ophthalmic1Product Code
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic1Product Code
- HRQHemostat1Product Code
- HSOSaw1Product Code
- HTCPliers, Surgical1Product Code
- HTDForceps1Product Code
- HTEElevator1Product Code
- HTFCurette1Product Code
- HTRRasp1Product Code
- HTZInstrument, Cutting, Orthopedic1Product Code
- HWMOsteotome1Product Code
- HXDClamp1Product Code
- HXLMallet1Product Code
- HXRSpatula, Orthopedic1Product Code
- HXTTape, Orthopedic1Product Code
- HYAForceps, Wire Holding1Product Code
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered2Product Code
- JCYCatheter, Infusion1Product Code
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered1Product Code
- JEBTable, Surgical With Orthopedic Accessories, Manual1Product Code
- JOSElectrode, Electrosurgical2Product Code
- JOTElectrode, Gel, Electrosurgical2Product Code
- JYCCannula, Ear1Product Code
- JYDChisel, Mastoid1Product Code
- KAMCannula, Sinus1Product Code
- KANChisel, Nasal1Product Code
- KCECannulae, Bronchial1Product Code
- KDCInstrument, Surgical, Disposable1Product Code
- KDDKit, Surgical Instrument, Disposable1Product Code
- KDGChisel (Osteotome)1Product Code
- KFKSaw, Pneumatically Powered1Product Code
- KGLCabinet, Phototherapy (Puva)2Product Code
- KGSRetention Device, Suture1Product Code
- KGWRing (Wound Protector), Drape Retention, Internal2Product Code
- KGYBag, Intestine1Product Code
- KGZAccessories, Catheter1Product Code
- KIKHook, Bone1Product Code
- KOXSolvent, Adhesive Tape1Product Code
- KOYDegreaser, Skin, Surgical1Product Code
- KOZBeads, Hydrophilic, For Wound Exudate Absorption1Product Code
- KQMCamera, Surgical And Accessories1Product Code
- LEJBooth, Sun Tan2Product Code
- LMFAgent, Absorbable Hemostatic, Collagen Based3Product Code
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based3Product Code
- LROGeneral Surgery Tray2Product Code
- LRPTray, Surgical1Product Code
- LRWScissors, General, Surgical1Product Code
- LRYPunch, Surgical1Product Code
- LRZScrewdriver, Surgical1Product Code
- LSAVise, Bench, Surgical1Product Code
- LWGSurgical Table Cushion1Product Code
- LWKRazor, Surgical1Product Code
- LXKScrapper, Skin Specimen1Product Code
- LXZGuard, Instrument1Product Code
- LYVLabel Or Tag, Sterile1Product Code
- LZMGuard, Skin Graft1Product Code
- MCHClip, Hemostatic2Product Code
- MCZSuture Removal Kit1Product Code
- MDAElastomer, Silicone, For Scar Management1Product Code
- MDMInstrument, Manual, Surgical, General Use1Product Code
- MGOClosure, Wound, Adhesive1Product Code
- MIJNeedle, Tumor Localization1Product Code
- MJGDevice, Percutaneous, Biopsy1Product Code
- MKYSystem, Skin Closure1Product Code
- MOQBattery, Replacement, Rechargeable1Product Code
- MPNTissue Adhesive For The Topical Approximation Of Skin2Product Code
- MULGenerator, Electrosurgical, Coagulation, Cancer2Product Code
- MUUSystem, Suction, Lipoplasty2Product Code
- MVRDevice, Anastomotic, Microvascular2Product Code
- MWYSystem, Microwave, Hair Removal2Product Code
- MXGLamp, Uvc, (For Treating Skin And Wounds)2Product Code
- MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)2Product Code
- NABGauze / Sponge,Nonresorbable For External Use1Product Code
- NACDressing, Wound, Hydrophilic1Product Code
- NADDressing, Wound, Occlusive1Product Code
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic1Product Code
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2Product Code
- NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)2Product Code
- NEHAnchor, Fascial2Product Code
- NEUMarker, Radiographic, Implantable2Product Code
- NEWSuture, Surgical, Absorbable, Polydioxanone2Product Code
- NEYSystem, Ablation, Microwave And Accessories2Product Code
- NJCClip, Vas Deferens2Product Code
- NJUSuture, Nonabsorbable, Nitinol2Product Code
- NJZExtractor, Vein1Product Code
- NLKNeedle, Biopsy, Cardiovascular, Reprocessed1Product Code
- NLLStaple, Implantable, Reprocessed2Product Code
- NMJClip, Implantable, Reprocessed2Product Code
- NMTNeedle, Catheter, Reprocessed1Product Code
- NMUNeedle, Gastro-Urology, Reprocessed1Product Code
- NNABiopsy Device, Percutaneous, Reprocessed1Product Code
- NNCNeedle, Aspiration And Needle, Reprocessed1Product Code
- NRBWound Cleaner, Ultrasound2Product Code
- NRJUltrasound, Skin Permeation2Product Code
- NTBSystem, Ablation, Ultrasound And Accessories2Product Code
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2Product Code
- NUVMassager, Vacuum, Light Induced Heating2Product Code
- NVHSuture, Knot, Mechanical2Product Code
- NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women2Product Code
- NWFDrill, Battery Powered, Subungual Hematoma1Product Code
- NWJSuture, Recombinant Technology2Product Code
- NXFGas, Laser Generating1Product Code
- NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)2Product Code
- OABLow Energy Direct Current Thermal Ablation System2Product Code
- ODRElectrosurgical Patient Return Electrode2Product Code
- OEIDrainage Catheter With Antibiotic2Product Code
- OELLaser, Benign Prostatic Hyperplasia2Product Code
- OHOFirst Aid Kit Without Drug1Product Code
- OHSLight Based Over The Counter Wrinkle Reduction2Product Code
- OHTLight Based Over-The-Counter Hair Removal2Product Code
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2Product Code
- OJJBurn Kit Without Drug1Product Code
- OJRVacuum Powered Body Fluid Collection Kit2Product Code
- OJTAspiration Tray1Product Code
- OJUSkin Prep Tray1Product Code
- OJVSingle Use Instrument Tray1Product Code
- OUHSkin Resurfacing Rf Applicator2Product Code
- OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite2Product Code
- OJWShave Prep Kit2Product Code
- OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-12Product Code
- OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus2Product Code
- OLPOver-The-Counter Powered Light Based Laser For Acne2Product Code
- OMDCutaneous Tissue Adhesive With Mesh2Product Code
- OMPNegative Pressure Wound Therapy Powered Suction Pump2Product Code
- ONEPowered Light Based Non-Laser Surgical Instrument2Product Code
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2Product Code
- ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output2Product Code
- ONQElectrosurgical Coagulation For Aesthetic2Product Code
- OOKDermal Cooling Pack/Vacuum/Massager2Product Code
- ORECryogenic, Skin Tag Removal, Otc2Product Code
- ORKLaser Assisted Lipolysis2Product Code
- OTKWound Drain Catheter System2Product Code
- OUBInstrument For Treatment Of Hyperhidrosis2Product Code
- OVNSuture Kit2Product Code
- OXTPercutaneous Surgical Set With Attachments2Product Code
- OYWLaser, Cellulite Appearance2Product Code
- PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction2Product Code
- PBXMassager, Vacuum, Radio Frequency Induced Heat2Product Code
- PBYTemporary Tissue Marker2Product Code
- PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.2Product Code
- PDWInternal Tissue Marker2Product Code
- PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis2Product Code
- PFPSilicone Hydrogel For Scar Management1Product Code
- PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use2Product Code
- PJKTissue Adhesive For Internal Use3Product Code
- PKDLaceration Tray1Product Code
- PKELaparoscopic Cholecystectomy Kit1Product Code
- PKOTransparent Patch For Use In Treatment Of Tattoos2Product Code
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2Product Code
- PMCScalp Cooling System2Product Code
- PMXAbsorbable Collagen Hemostatic Agent With Thrombin3Product Code
- PNLMagnetic Surgical System2Product Code
- PODTemporary, Internal Use Hemostatic2Product Code
- PQIWound Retraction And Protection System2Product Code
- PSNLight Based Imaging2Product Code
- PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt2Product Code
- PUIDrape, Surgical, Exempt2Product Code
- PXNBasic Set-Up Tray1Product Code
- PXOBone Marrow Biopsy Tray1Product Code
- PXPBreast Biopsy / Localization Tray1Product Code
- QRLMultiple Use Blood Lancet For Single Patient Use Only2Product Code
- PXQBurn Dressing Tray1Product Code
- PXRCement And Bone Removal Kit1Product Code
- PXSCholecystectomy Kit1Product Code
- PXUFluid Drainage Tray1Product Code
- PXVGeneral Purpose Instrument Tray1Product Code
- PXWHerniorraphy Kit1Product Code
- PXXIncision Tray1Product Code
- PXYIrrigation Kit (Wounds)1Product Code
- PXZLaparascopic Sphincterotomy Kit1Product Code
- PYALiver Biopsy Kit1Product Code
- PYBMinor Surgical Procedures Tray1Product Code
- PYCParacentesis Tray1Product Code
- PYDPelviscopy Kit1Product Code
- PYEStaple Removal Kit1Product Code
- PYFSterile Puncture Tray1Product Code
- PYGSuction Catheter Kit1Product Code
- PYHSurgical Retractor Kit1Product Code
- PYIThoracic Catheter Insertion Tray1Product Code
- PYJUlcer Wound Tray1Product Code
- PYKVenous Ulcer Kit1Product Code
- PYLWound Drainage Kit1Product Code
- PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers2Product Code
- PZQGeneral Laparoscopic Power Morcellation Containment System2Product Code
- QAIPowered Microneedle Device2Product Code
- QAUHemostatic Device For Endoscopic Gastrointestinal Use2Product Code
- QCRWound Autofluorescence Imaging Device2Product Code
- QCYLaser Absorbing Particles2Product Code
- QDFParathyroid Autofluorescence Detection Device2Product Code
- QDGParathyroid Autofluorescence Imaging Device2Product Code
- QRMMultiple Use Blood Lancet For Multiple Patient Use3Product Code
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications2Product Code
- QHFEnergy Based Device For Treatment Of Tattoos2Product Code
- QJFAutofluorescence Imaging Adjunct Tool For Wounds2Product Code
- QKLLipoaspirate Washing System For Aesthetic Body Contouring2Product Code
- QNMMountable Electromechanical Surgical System For Transluminal Approaches2Product Code
- QPBSystem, Suction, Lipoplasty For Removal2Product Code
- QPXNegative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical2Product Code
- QPZContact Cooling For Skin Lesion Pain Relief2Product Code
- RABSunlamp Products (Pre-Standard)2Product Code
- REFSuntan Bed2Product Code
- REGSuntan Lamp2Product Code
- REHTabletop Sunlamp System2Product Code
- QUBSuction Lipoplasty System For Removal And Transfer2Product Code
- QVJLow Power Electrosurgical Devices For Skin Lesion Destruction2Product Code
- QZNMulti-Photon Imaging2Product Code
- 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
Burn Kit Without Drug
- Page Type
- Product Code
- Definition
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Physical State
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Technical Method
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Target Area
- This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- General and Plastic Surgery
- Submission Type
- Enforcement Discretion
- Device Classification
- Class 1
- Regulation Number
- 878.4022
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 878.4022 Hydrogel wound dressing and burn dressing
§ 878.4022 Hydrogel wound dressing and burn dressing.
(a) Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
[64 FR 53929, Oct. 5, 1999]