Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- FADStent, Ureteral2Product Code
- EXXProbe, Rectal, Non-Powered1Product Code
- EYDStirrups1Product Code
- EYHTable, Cysto, Non-Electrical1Product Code
- EYSRibdam1Product Code
- EZOUrethrotome2Product Code
- EZPRod, Colostomy2Product Code
- FARUnit, Electrosurgical2Product Code
- FASElectrode, Electrosurgical, Active, Urological2Product Code
- FBJCord, Electric For Transurethral Surgical Instrument2Product Code
- FBSSound, Metal, Interconnected1Product Code
- FCHTray, Biopsy, Without Biopsy Instruments1Product Code
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral2Product Code
- FDBPlate, Patient2Product Code
- FDGRetractor, Fiberoptic1Product Code
- FDISnare, Flexible2Product Code
- FDJSnare, Rigid Self-Opening2Product Code
- FDLWristlet, Patient Return2Product Code
- FEHElectrode, Flexible Suction Coagulator2Product Code
- FEOLithotriptor, Ultrasonic2Product Code
- FFDEvacuator, Bladder, Manually Operated1Product Code
- FFESystem, Water Jet Catheter, Renal2Product Code
- FFISystem, Alarm, Electrosurgical2Product Code
- FFKLithotriptor, Electro-Hydraulic2Product Code
- FFLDislodger, Stone, Basket, Ureteral, Metal2Product Code
- FFNClamp, Non-Electrical1Product Code
- FFORetractor, Self-Retaining1Product Code
- FFQSpeculum, Rectal1Product Code
- FFRDevice, Locking, For Intestinal Clamp1Product Code
- FGKTripsor, Stone, Bladder2Product Code
- FGMProbe And Director, Gastro-Urology1Product Code
- FGNRetractor, Non-Self-Retaining1Product Code
- FGODislodger, Stone, Flexible2Product Code
- FGWClamp, Electrical2Product Code
- FGXSnare, Non-Electrical1Product Code
- FHBHook, Gastro-Urology1Product Code
- FHCAdaptor To The Cord, For Transurethral Surgical Instrument2Product Code
- FHFSystem, Evacuator, Fluid2Product Code
- FHHCrusher, Spur, Colostomy1Product Code
- FHIRing, Laparotomy1Product Code
- FHKSpreader, Bladder Neck1Product Code
- FHLScoop1Product Code
- FHNLigator, Hemorrhoidal2Product Code
- FHQHolder, Needle, Gastroenterologic1Product Code
- FHYJelly, Contact, For Transurethral Surgical Instrument2Product Code
- FHZDesiccator, Transurethral2Product Code
- FKKClamp, Line1Product Code
- KGEForceps, Biopsy, Electric2Product Code
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2Product Code
- K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)2Cleared 510(K)
- K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)2Cleared 510(K)
- K251104SureTome™ SW Sphincterotome with DomeTip2Cleared 510(K)
- K251226Aqua Medical RF Vapor Ablation System2Cleared 510(K)
- K250584Rezum System2Cleared 510(K)
- K242774SpydrBlade Flex Instrument (PRD-RG1-001)2Cleared 510(K)
- K241855SB Knife Jr2 (MD-47702 and MD-47702L)2Cleared 510(K)
- K242192Disposable Sphincterotome2Cleared 510(K)
- K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord2Cleared 510(K)
- K241271Aqua Medical RF Vapor Ablation System2Cleared 510(K)
- K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)2Cleared 510(K)
- K232825Disposable Sphincterotome2Cleared 510(K)
- K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter2Cleared 510(K)
- K232476Disposable Sphincterotome2Cleared 510(K)
- K230328Speedboat Flush SB1 Instrument2Cleared 510(K)
- K233318AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)2Cleared 510(K)
- K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)2Cleared 510(K)
- K232162Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome2Cleared 510(K)
- K231533Habib EndoHPB2Cleared 510(K)
- K222421Sphincterotome2Cleared 510(K)
- K223256Optimos™ Cystotome2Cleared 510(K)
- K222542MCB UNIT Model: V10GMCBUS2Cleared 510(K)
- K211909Cysto-Gastro-Sets2Cleared 510(K)
- K212999Multi-Functional Electrosurgical Knife2Cleared 510(K)
- K213627RF Vapor System2Cleared 510(K)
- K210934Sphincterotome / short-wire compatible, Sterile Sphincterotome2Cleared 510(K)
- K211282Aqua Medical RF Vapor System2Cleared 510(K)
- K201121Sphincterotome2Cleared 510(K)
- K200404ORISE ProKnife2Cleared 510(K)
- K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)2Cleared 510(K)
- K192905Creo Electrosurgical System with HS1 Hemostasis Accessory2Cleared 510(K)
- K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord2Cleared 510(K)
- K193039Single Use Balloon Dilator V (with knife)2Cleared 510(K)
- K191505Rezum System2Cleared 510(K)
- K183595Aqua Medical RF Vapor System2Cleared 510(K)
- K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-6452Cleared 510(K)
- K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long2Cleared 510(K)
- K181758ELRA Electrode2Cleared 510(K)
- K190093Rezum Delivery Device, Rezum Generator2Cleared 510(K)
- K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords2Cleared 510(K)
- K172288Fusion OMNI Sphincterotome2Cleared 510(K)
- K180165Habib EndoHPB2Cleared 510(K)
- K180237Rezum System2Cleared 510(K)
- K173559Barrx SB RFA Endoscopic Catheter2Cleared 510(K)
- K171158Single Use Electrosurgical knife2Cleared 510(K)
- K171993Zimmon Needle Knife Papillotome2Cleared 510(K)
- K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory2Cleared 510(K)
- K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long2Cleared 510(K)
- K160417Rezum System2Cleared 510(K)
- K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-02152Cleared 510(K)
- K150142Single Use Balloon Dilator V (with Knife)2Cleared 510(K)
- K150786Rezum System2Cleared 510(K)
- K141991SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP2Cleared 510(K)
- K133933INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER2Cleared 510(K)
- K130623BARRX CHANNEL RFA ENDOSCOPIC CATHETER2Cleared 510(K)
- K122505SINGLE USE PRELOADED SPHINCTEROTOME V2Cleared 510(K)
- K123319GYRUS ACMI BICOAG HEMOSTASIS PROBE2Cleared 510(K)
- K122203TRUETOME2Cleared 510(K)
- K110887INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER2Cleared 510(K)
- K092571GYRUS ACMI BIOCOAG PROBE2Cleared 510(K)
- K102273MERIT BIPOLAR COAGULATION PROBE2Cleared 510(K)
- K093079TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U2Cleared 510(K)
- K101139PROSTIVA RF THERAPY MODEL 8929 HAND PIECE2Cleared 510(K)
- K092309SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L2Cleared 510(K)
- K083292HABIB ENDOHPB2Cleared 510(K)
- K083275PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-22Cleared 510(K)
- K082114ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-002Cleared 510(K)
- K082464PROSTIVA RF THERAPY HAND PIECE, MODEL 89292Cleared 510(K)
- K080946CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX2Cleared 510(K)
- K072383HABIB ENDOBLATE2Cleared 510(K)
- K061684MEDI-GLOBE ROTA-CUT SPHINCTEROTOME2Cleared 510(K)
- K052413TUNA SYSTEM, MODELS 8909, 8929, 8930, 89342Cleared 510(K)
- K052051OMNI SPHINCTEROTOME2Cleared 510(K)
- K050578COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE2Cleared 510(K)
- K033135STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM2Cleared 510(K)
- K040981USW NEEDLEKNIFE PAPILLOTOME2Cleared 510(K)
- K033203WILSON-COOK TRI-TOME SELECT PLUS2Cleared 510(K)
- K031026ETI BIPOLAR HEMOSTATIC PROBE2Cleared 510(K)
- K030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT2Cleared 510(K)
- K030315MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM2Cleared 510(K)
- K023706ULTROID HEMORRHOID MANAGEMENT SYSTEM2Cleared 510(K)
- K022595WILSON-COOK CYSTOTOME2Cleared 510(K)
- K021266ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW0182Cleared 510(K)
- K012587RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE2Cleared 510(K)
- K013153AUTOTOME RX MODEL # 4515, 45162Cleared 510(K)
- K011787PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE2Cleared 510(K)
- K010568ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM2Cleared 510(K)
- K002583TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM2Cleared 510(K)
- K002236HORIZONS PAPILLOTOME2Cleared 510(K)
- K003569PLASMAKINETIC ENDOUROLOGY SYSTEM2Cleared 510(K)
- K002802RAPID EXCHANGE TAPERTOME2Cleared 510(K)
- K000508THERMOFLEX SYSTEM2Cleared 510(K)
- K994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE2Cleared 510(K)
- K9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH2Cleared 510(K)
- K991847THERMOFLEX SYSTEM2Cleared 510(K)
- K990628GYRUS ENDOUROLOGY SYSTEM2Cleared 510(K)
- K990852COOPERSURGICAL INFRARED COAGULATOR2Cleared 510(K)
- K990850COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL2Cleared 510(K)
- K990376BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME2Cleared 510(K)
- K990855COOPERSURGICAL INFRARED COAGULATOR FOR ENT2Cleared 510(K)
- K990145WILSON-COOK BIPOLAR PROBE2Cleared 510(K)
- K982557BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES2Cleared 510(K)
- K982289HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##2Cleared 510(K)
- K974168COOPERSURGICAL INFRARED COAGULATOR2Cleared 510(K)
- K973826SPHINCTEROTOME2Cleared 510(K)
- K973366COBRA HAND PIECE2Cleared 510(K)
- K972674WILSON-COOK NEEDLE KNIFE PAPILLOTOME2Cleared 510(K)
- K970945ANGLED TIP POLYPECTOMY SNARE2Cleared 510(K)
- K970278MICROVASIVE GOLD PROBE2Cleared 510(K)
- K970053ULTRATOMERX2Cleared 510(K)
- K963484BARD HIGH FLOW PAPILLOTOME2Cleared 510(K)
- K962083KARL STORZ REMORGIDA FORCEPS2Cleared 510(K)
- K962346PAPILLOTOME2Cleared 510(K)
- K960231SPHINCTEROTOME2Cleared 510(K)
- K961762REUSABLE ENDOSCOPIC ACCESSORY HANDLE2Cleared 510(K)
- K961349INJECTION GOLD PROBE2Cleared 510(K)
- K955247OLYMPUS KD SERIES SPHINCTEROTOME2Cleared 510(K)
- K946109CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS2Cleared 510(K)
- K943629GIP/MEDI-GLOBE PAPILLOTOME2Cleared 510(K)
- K950836REDFIELD INFRARED COAGULATOR2Cleared 510(K)
- K950166OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE2Cleared 510(K)
- K945764HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP2Cleared 510(K)
- K944955AESCULAP THORACOSCOPIC INSTRUMENTS2Cleared 510(K)
- K942301MICROVASIVE INJECTION GOLD PROBE2Cleared 510(K)
- K932293CABOT MEDICAL BIPOLAR CUTTING FORCEPS2Cleared 510(K)
- K941728MONOPOLAR COAGULATING POLYPECTOMY SNARE2Cleared 510(K)
- K942068AMERICAN CATHETER SPHINCTEROTOME2Cleared 510(K)
- K934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME2Cleared 510(K)
- K921029DOBBHOFF BIPOLAR ADAPTER2Cleared 510(K)
- K920089MONOPOLAR COAGULATING POLYPECTOMY SNARE2Cleared 510(K)
- K915408BIPOLAR ENDOSTASIS PROBE, BEST (TM)2Cleared 510(K)
- K913881ENDOSTAT ELECTROSURGICAL UNIT2Cleared 510(K)
- K912129DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE2Cleared 510(K)
- K911648REDFIELD INFRARED COAGULATOR2Cleared 510(K)
- K911600ILCO INFRARED LIGHT COAGULATOR2Cleared 510(K)
- K911700MONOPOLAR POLLYPECTOMY SNARE2Cleared 510(K)
- K912601BIPROBE(TM)2Cleared 510(K)
- K903323RESECTOSCOPE LOOPS2Cleared 510(K)
- K901443ZIMMON PAPILLOTOME2Cleared 510(K)
- K896612DOBBHOFF(R) PAPILLOTOME2Cleared 510(K)
- K896507PORGES DIATHERMY SNARE2Cleared 510(K)
- K896426PORGES SPHINCTEROTOMES2Cleared 510(K)
- K895855PHOENIX2Cleared 510(K)
- K895842BITOME(TM) BIPOLAR SPHINCTEROTOME2Cleared 510(K)
- K894861WILTEK PAPILLOTOME2Cleared 510(K)
- K892895MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM2Cleared 510(K)
- K884025CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-2002Cleared 510(K)
- K885005MICROVASIVE GOLD PROBE2Cleared 510(K)
- K884254CIRCON ACMI BICAP III THERAPEUTIC SYSTEM2Cleared 510(K)
- K884252CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-202Cleared 510(K)
- K884306BICAP ABLATING FORCEPS BAF-72Cleared 510(K)
- K882048MEDITRON ENDOLAV MODEL EL-1002Cleared 510(K)
- K880748BALL TIP FULGURATING ELECTRODE, 3 FRENCH2Cleared 510(K)
- K870705THERMAL COAGULATOR2Cleared 510(K)
- K864413MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE2Cleared 510(K)
- K861904HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE2Cleared 510(K)
- K860593ET/RT PAPILLOTOME2Cleared 510(K)
- K862060POLYPECTOMY SNARE2Cleared 510(K)
- K860366CHALLENGER HOT BIOPSY FORCEPS2Cleared 510(K)
- K853680ENDODYNAMIC SIEGEL SPHINCTEROTOME2Cleared 510(K)
- K851958ROTATABLE POLYPECTOMY SNARE POS-12Cleared 510(K)
- K851652PAPILLOTOME2Cleared 510(K)
- K851964E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE2Cleared 510(K)
- K851096HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM2Cleared 510(K)
- K845015DAVOL PAPILLITOME2Cleared 510(K)
- K842810INFRARED COAGULATOR2Cleared 510(K)
- K820430DIATHERMIC SNARES2Cleared 510(K)
- K820240PAPILLOTOMES2Cleared 510(K)
- K820405GROUND AID CAPHESIVE2Cleared 510(K)
- K820196ELECTROSURGICAL DISP. DISPERSIVE PAD2Cleared 510(K)
- K813434ELECTROSURGICAL DISP. DISPERSIVE PAD2Cleared 510(K)
- K812213AUTOMATED ELECTROCAUTERY SYSTEM2Cleared 510(K)
- K810336POLYPECTOMY SNARE2Cleared 510(K)
- K802444PAPILLOTOME PRODUCT2Cleared 510(K)
- K800915JOHNLOZ ENDOSCOPY HANDLE2Cleared 510(K)
- K800965M.R. ASSOC. SNARES; CRESCENT SNARE WIRE2Cleared 510(K)
- K800973M.R. ASSOC. HOT BIOPSY FORCEPS2Cleared 510(K)
- K800974M.R. ASSOC. POWER CORD2Cleared 510(K)
- K800975M.R. ASSOC. TRUE-FEEL HANDLE2Cleared 510(K)
- K800964M.R. ASSOC. BALL TYPE COAGULATOR2Cleared 510(K)
- K800321CONCEPT SUCTION COAGULATOR2Cleared 510(K)
- K781353PAPILLOTOME CUTTING SNARE2Cleared 510(K)
- K780774PAPILLOTOMY KNIVES2Cleared 510(K)
- K770280CORD, ELECTROSURGICAL-STERILE & DISPOS.2Cleared 510(K)
- K760178ELECTRODE, CUTTING LOOP2Cleared 510(K)
- KOASurgical Instruments, G-U, Manual (And Accessories)1Product Code
- KQSTable, Cystometric, Non-Electric And Accessories1Product Code
- KQTEvacuator, Gastro-Urology2Product Code
- LQCLithotriptor, Biliary Mechanical2Product Code
- MMZTable, Cystometric, Electric2Product Code
- MNDLigator, Esophageal2Product Code
- NLRUnit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed2Product Code
- NLTSnare, Flexible, Reprocessed2Product Code
- NLUForceps, Biopsy, Electric, Reprocessed2Product Code
- NLVElectrode, Flexible Suction Coagulator, Reprocessed2Product Code
- NLWElectrode, Electrosurgical, Active, Urological, Reprocessed2Product Code
- NQTDislodger, Stone, Flexible, Ureteral, Reprocessed2Product Code
- NQUDislodger, Stone, Basket, Ureteral, Metal, Reprocessed2Product Code
- NWIElectrosurgical Electrode Kit2Product Code
- OLHOrchidometer1Product Code
- ONJDissolvable Gel For Preventing Ureteral Stone Migration2Product Code
- OOWApplicator For Rectal Suppository1Product Code
- PKLHemostatic Metal Clip For The Gi Tract2Product Code
- PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation2Product Code
- PRUGastric Lavage Kit (Adult Or Pediatric Use)2Product Code
- QGBUreteral Stent Accessories1Product Code
- PVYVasovasostomy Set1Product Code
- QNEEndoscopic Pancreatic Debridement Device2Product Code
- QAGEndoscopic Electrosurgical Clip Cutting System2Product Code
- LNKLaser For Gastro-Urology Use2Product Code
- MUKElectrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue2Product Code
- NEJSystem, Cryosurgical, Liquid Nitrogen, For Gastroenterology2Product Code
- PZPFluid Jet Removal System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Rezum System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K191505
- 510(k) Type
- Special
- Applicant
- NxThera (A Boston Scientific Company)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/2019
- Days to Decision
- 57 days
- Submission Type
- Summary