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
- K251646extriCARE® 1000 Negative Pressure Wound Therapy System2Cleared 510(K)
- K251826RENASYS WOUND+ Dressing Kit with AIRLOCK Technology2Cleared 510(K)
- K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)2Cleared 510(K)
- K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port2Cleared 510(K)
- K233614Genadyne DUO NPWT2Cleared 510(K)
- K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)2Cleared 510(K)
- K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)2Cleared 510(K)
- K241515NEXA™ NPWT System2Cleared 510(K)
- K231939Renasys Edge2Cleared 510(K)
- K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)2Cleared 510(K)
- K230233Prospera Spectruum Negative Pressure Wound Therapy System2Cleared 510(K)
- K231646Carilex VT¿200-i NX2Cleared 510(K)
- K232379PREVENT Kit2Cleared 510(K)
- K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)2Cleared 510(K)
- K223388Invia® Integrated Dressing2Cleared 510(K)
- K221888Genadyne Hybrid Foam Dressings2Cleared 510(K)
- K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)2Cleared 510(K)
- K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit2Cleared 510(K)
- K213906extriCARE 1000 Negative Pressure Wound Therapy System2Cleared 510(K)
- K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large2Cleared 510(K)
- K221223extriCARE® 3000 Negative Wound Pressure Therapy System2Cleared 510(K)
- K221891UNO Negative Pressure Wound Therapy System2Cleared 510(K)
- K223041Renasys Edge (66803126)2Cleared 510(K)
- K212359PWD Negative Pressure Wound Therapy System2Cleared 510(K)
- K214112Invia Ease Negative Pressure Wound Therapy (NPWT) System2Cleared 510(K)
- K220560Dermatac Drape2Cleared 510(K)
- K220660Prevena Restor Adapti-Form Dressing2Cleared 510(K)
- K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System2Cleared 510(K)
- K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit2Cleared 510(K)
- K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing2Cleared 510(K)
- K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs2Cleared 510(K)
- K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) System2Cleared 510(K)
- K2115213M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)2Cleared 510(K)
- K211277Theia NPWT Foam Wound Dressing Kit2Cleared 510(K)
- K202823Innomed NPWT Silicone Foam Dressing2Cleared 510(K)
- K203316V.A.C.ULTA Negative Pressure Wound Therapy System2Cleared 510(K)
- K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac2Cleared 510(K)
- K203693Nisus Touch Negative Pressure Wound Therapy Pump2Cleared 510(K)
- K203369Avance Solo Negative Pressure Wound Therapy (NPWT) System2Cleared 510(K)
- K202217Kendall NPWT Incision Management Device2Cleared 510(K)
- K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack2Cleared 510(K)
- K200223PocketDoc™ Micro Wound Therapy System2Cleared 510(K)
- K191101Kendall NPWT Incision Management Dressing Kit2Cleared 510(K)
- K201571ACTIV.A.C. Negative Pressure Wound Therapy System2Cleared 510(K)
- K200390V.A.C. DERMATAC Drape2Cleared 510(K)
- K190028UNO 302Cleared 510(K)
- K191760PICO 14 Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)2Cleared 510(K)
- K190119Foryou NPWT Dressing Kit2Cleared 510(K)
- K182722XLR8 Abdominal Wound Dressing Kit2Cleared 510(K)
- K191460PWD Platform Wound Dressing 3” x 5” Oblong2Cleared 510(K)
- K182458Longterm NPWT Foam Dressing Kit2Cleared 510(K)
- K181505V.A.C. DERMATAC Drape2Cleared 510(K)
- K181929MiMo(TM) Negative Pressure Wound Therapy System2Cleared 510(K)
- K181822RENASYS Touch; RENASYS Y-Connector2Cleared 510(K)
- K183543ACTIV.A.C. Therapy Unit2Cleared 510(K)
- K181507PREVENA RESTOR(TM) Incision Management System2Cleared 510(K)
- K182191Invia Abdominal Dressing Kit2Cleared 510(K)
- K182323PICO 7Y Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K182409Applied Tissue Technologies PWD™ Platform Wound Dressing2Cleared 510(K)
- K181204RENASYS Y-Connector; RENASYS TOUCH2Cleared 510(K)
- K180840UNO Negative Pressure Wound Therapy System2Cleared 510(K)
- K180415Invia White Foam NPWT2Cleared 510(K)
- K180205AVELLE Negative Pressure Wound Therapy System2Cleared 510(K)
- K180698PICO 7 Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K173407VT - 100, VT - 2002Cleared 510(K)
- K172725VT Dressing Kits2Cleared 510(K)
- K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System2Cleared 510(K)
- K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad2Cleared 510(K)
- K180618PICO Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K180614PICO Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System2Cleared 510(K)
- K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit2Cleared 510(K)
- K172005PICO 7 Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K171499Occlusion Detection Dressing Kit2Cleared 510(K)
- K172521PICO Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K172519PICO Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K162610NEXA Negative Pressure Wound Therapy System2Cleared 510(K)
- K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing2Cleared 510(K)
- K163387PICO Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film2Cleared 510(K)
- K161599UNO Negative Pressure Wound Therapy System2Cleared 510(K)
- K161432MyNeWT Negative Pressure Wound Therapy System2Cleared 510(K)
- K162790V.A.C.ULTA Negative Pressure Wound Therapy System2Cleared 510(K)
- K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set2Cleared 510(K)
- K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System2Cleared 510(K)
- K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply2Cleared 510(K)
- K150960WoundPro Negative Pressure Wound Therapy System2Cleared 510(K)
- K161935Avance Foam Dressing Kit - XL2Cleared 510(K)
- K161948Avance Gauze Dressing Kits2Cleared 510(K)
- K161797Avance Tubing, Avance Y-Connector, Avance ViewPad2Cleared 510(K)
- K161410VT·One, VT·One 60days2Cleared 510(K)
- K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings2Cleared 510(K)
- K152163RENASYS GO2Cleared 510(K)
- K162129RENASYS-G Gauze Dressing Kits with Soft Port2Cleared 510(K)
- K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large2Cleared 510(K)
- K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply2Cleared 510(K)
- K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...2Cleared 510(K)
- K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack2Cleared 510(K)
- K151263Venturi Gauze Wound Care Sets with Portal Drain2Cleared 510(K)
- K151436PICO Single Use Negative Pressure Wound Therapy System2Cleared 510(K)
- K152741Mepiseal Soft Silicone Sealant2Cleared 510(K)
- K150459FloSure Ventilation Patch2Cleared 510(K)
- K143004VENTURI MiNO TG600/142Cleared 510(K)
- K150006Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing2Cleared 510(K)
- K151872Avance Y-Connector S2Cleared 510(K)
- K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large2Cleared 510(K)
- K150124Cardinal Health NPWT PRO HC2Cleared 510(K)
- K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,2Cleared 510(K)
- K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device2Cleared 510(K)
- K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device2Cleared 510(K)
- K143726XLR8 PLUS (XLR8+)2Cleared 510(K)
- K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters2Cleared 510(K)
- K151240extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc2Cleared 510(K)
- K142385Whisper Pump System2Cleared 510(K)
- K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and2Cleared 510(K)
- K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters2Cleared 510(K)
- K143016Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home2Cleared 510(K)
- K141961GENADYNE SPIRO FOAM DRESSING KIT2Cleared 510(K)
- K141847AVANCE FOAM DRESSING KITS2Cleared 510(K)
- K142916SVED Wound Treatment System2Cleared 510(K)
- K143301NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit2Cleared 510(K)
- K142956NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit2Cleared 510(K)
- K143362extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister2Cleared 510(K)
- K133333UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT2Cleared 510(K)
- K141926INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM2Cleared 510(K)
- K140022NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT2Cleared 510(K)
- K141437XLR8 PLUS (XLR8+)2Cleared 510(K)
- K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit2Cleared 510(K)
- K141033SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV2Cleared 510(K)
- K132225EXTRICARE2Cleared 510(K)
- K132004NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE2Cleared 510(K)
- K133232PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES2Cleared 510(K)
- K132936NOVOPORE DRESSING2Cleared 510(K)
- K133276V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS2Cleared 510(K)
- K132741V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM2Cleared 510(K)
- K122490KULAVAC2Cleared 510(K)
- K132446RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE2Cleared 510(K)
- K132252EXTRICARE 100CC/ 250CC/ 400CC CANISTERS2Cleared 510(K)
- K121817VCARE A2Cleared 510(K)
- K131464EXTRICARE NPWT FOOT DRESSING2Cleared 510(K)
- K123507KCI NPWT GAUZE DRESSING2Cleared 510(K)
- K113236FORYOU NPWT DEVICE2Cleared 510(K)
- K122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM2Cleared 510(K)
- K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING2Cleared 510(K)
- K112853VOLTERA POWERED SUCTION PUMP2Cleared 510(K)
- K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT2Cleared 510(K)
- K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM2Cleared 510(K)
- K113678INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM2Cleared 510(K)
- K113291SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX3002Cleared 510(K)
- K113199KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT2Cleared 510(K)
- K111949AC WOUND TREATMENT SYSTEM2Cleared 510(K)
- K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT2Cleared 510(K)
- K112127PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM2Cleared 510(K)
- K110078EXTRICARE2Cleared 510(K)
- K112458PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM2Cleared 510(K)
- K111170PICO2Cleared 510(K)
- K111333ANTLIA III WOUND TREATMENT SYSTEM2Cleared 510(K)
- K111280V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT2Cleared 510(K)
- K110647RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS2Cleared 510(K)
- K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEM2Cleared 510(K)
- K100823WOUND PRO APEX2Cleared 510(K)
- K102956V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING2Cleared 510(K)
- K100657V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U2Cleared 510(K)
- K102001MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY2Cleared 510(K)
- K092992A4-XLR8 FOAM DRESSING2Cleared 510(K)
- K100821PREVENA INCISION MANAGEMENT SYSTEM2Cleared 510(K)
- K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D2Cleared 510(K)
- K091585VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 3201002Cleared 510(K)
- K093564SVED WOUND TREATMENT SYSTEM2Cleared 510(K)
- K090258VENTURI NPWT V. II ADVANCED VACUUM SYSTEM2Cleared 510(K)
- K091470RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 668000592Cleared 510(K)
- K090638GENADYNE A4-XLR8 WOUND VACUUM SYSTEM2Cleared 510(K)
- K090130ATMOS S041 WOUND2Cleared 510(K)
- K083357OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 3705102Cleared 510(K)
- K083375RENASYS GO NEGATIVE PRESSURE WOUND THERAPY2Cleared 510(K)
- K082676GENADYNE A4 WOUND VACUUM SYSTEM2Cleared 510(K)
- K082415PRODIGY NPWT SYSTEM MODEL PRODIGY 800V2Cleared 510(K)
- K082211RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS2Cleared 510(K)
- K080275NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM2Cleared 510(K)
- K082311EXSUDEX WOUND DRAINAGE PUMP2Cleared 510(K)
- K082426RENASYS EZ2Cleared 510(K)
- K080357MEDELA INVIA WOUND THERAPY2Cleared 510(K)
- K080897VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM2Cleared 510(K)
- K063740V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M62577662Cleared 510(K)
- K063692V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 3400002Cleared 510(K)
- K071301ANTLIA I WOUND IRRIGATION SYSTEM2Cleared 510(K)
- K070904ANTLIA II SUCTION PUMP SYSTEM2Cleared 510(K)
- K061919VERSATILE 1 EZCARE WOUND VACUUM SYSTEM2Cleared 510(K)
- K063590V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M62754232Cleared 510(K)
- K063426V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/102Cleared 510(K)
- K062456NOVASPINE POWERED SUCTION PUMP PRO-12Cleared 510(K)
- K062227V.A.C. THERAPY SYSTEM2Cleared 510(K)
- K061367BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.05002Cleared 510(K)
- K061788BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM2Cleared 510(K)
- K061435MEDELA VARIO SUCTION PUMPS2Cleared 510(K)
- K053627MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING2Cleared 510(K)
- K052456MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM2Cleared 510(K)
- K050261V.A.C. GRANUFOAM SILVER PROTECTION DRESSING2Cleared 510(K)
- K041642V.A.C. GRANUFOAM SILVER DRESSING2Cleared 510(K)
- K042134VERSATILE 1 WOUND VACUUM SYSTEM2Cleared 510(K)
- K032310MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS2Cleared 510(K)
- K032301NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG99002Cleared 510(K)
- K021500VACUUM ASSISTED CLOSURE2Cleared 510(K)
- K021501V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT2Cleared 510(K)
- K992448V.A.C. PLUS2Cleared 510(K)
- K971548AMBUVAC2Cleared 510(K)
- 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
- SFGCamera, Surgical, Measurement1Product 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
RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large
- Page Type
- Cleared 510(K)
- 510(k) Number
- K213853
- 510(k) Type
- Traditional
- Applicant
- Smith and Nephew Medical Limited
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/10/2023
- Days to Decision
- 427 days
- Submission Type
- Summary