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Gastroenterology, Urology

11,291 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK (K093653)Uresil, LLC2010-02-23
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 (K093718)Zutron Medical, LLC2010-02-22
DIALOG WITH ADIMEA OPTION (K083460)B. Braun Avitum AG2010-02-18
DURASPAN HEMODIALYSIS LONG-TERM CATHETER (K100169)R4 Vascular, Inc.2010-02-18
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 (K093120)Baxter Healthcare Corporation - Renal Division2010-02-17
SCOPE INTRODUCER MODEL 7400 (K093329)N.M. Beale Co., Inc.2010-02-16
MINI LAP RETRACTORS (K093449)Mini Lap Technologies, Inc.2010-02-12
ENDOSCOPE REPROCESSOR OER-PRO (K093106)Olympus Medical Systems Corporation2010-02-12
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 (K093637)Jms North America Corp.2010-02-09
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM (K093379)Bl Healthcare, Inc.2010-02-09
TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 (K092821)Agency For Medical Innovations, Inc.2010-02-01
ALPHAXENON LIGHT 180 W AND 300 W (K093125)Gimmi GmbH2010-01-27
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (K093985)Nipro Medical Corp.2010-01-22
LAPAROSCOPIC RETRACTORS (K092684)Cardinal Health, Inc.2010-01-22
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC (K093947)Merit Medical Systems, Inc.2010-01-21
MEDLINE RED RUBBER URETHRAL CATHETER (K092250)Medline Industries, Inc.2010-01-21
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) (K093217)Intuitive Surgical, Inc.2010-01-21
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O (K093195)Cook Ireland, Ltd.2010-01-21
PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX (K082805)Q Urological Corporation2010-01-20
MODERN MEDICAL RESECTOSCOPE ELECTRODES (K091511)Modern Medical Equipment Mfg., Ltd.2010-01-15
MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE (K092739)C-Link Micro Imaging, Inc.2010-01-12
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 (K091506)R4 Vascular, Inc.2010-01-08
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS (K093392)Navilyst Medical, Inc.2009-12-31
PENTEX EC-3890LI (K093037)Pentax Medical Company2009-12-28
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART (K093616)Carefusion 22002009-12-23
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 (K090993)Intuitive Surgical, Inc.2009-12-16
ENDOFLIP (K092850)Crospon, Ltd.2009-12-15
ENDO SMARTCAP (K093665)Byrne Medical, Inc.2009-12-15
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM (K093312)Kimberly-Clark Corp.2009-12-08
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM (K093600)Accelerated Care Plus2009-12-04
SILS PORT MODEL SILSPT15 (K093372)Covidien Lp, Formerly Registered AS Tyco Healthcar2009-12-03
PENTAX ED-3490TK, VIDEO DUODENOSCOPE (K092710)Pentax Medical Company2009-12-02
INSERTEASE (K092829)Christcot Medical Company2009-12-02
ERBELIFT HAND PUMP AND FLEXIBLE PROBE (K092090)Byrne Medical, Inc.2009-11-30
MULTI-BITE HOT BIOPSY FORCEPS (K090796)Endo-Therapeutics, Inc.2009-11-25
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM (K083770)Coloplast A/S2009-11-23
ENCOR BREAST BIOPSY SYSTEM (K093512)Senorx, Inc.2009-11-20
ACUTE AND CHRONIC CATHETER REPAIR KIT (K092797)Kendall2009-11-19
ENDOGATOR (K092429)Byrne Medical, Inc.2009-11-19
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 (K090682)Edwards Lifesciences Services GmbH2009-11-19
PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 (K093399)Inrad2009-11-19
SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 (K093256)Inrad2009-11-17
CENTROS CHRONIC HEMODIALYSIS CATHETER SET (K092597)Ash Access Technology, Inc.2009-11-12
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US (K093068)C.R. Bard, Inc.2009-11-10
ETHICON ENDO-SURGERYOPTICAL DILATOR (K093236)Ethicon Endo-Surgery, Inc.2009-11-10
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 (K092400)Endogastric Solutions, Inc.2009-11-06
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM (K092504)Surgiquest, Inc.2009-11-05
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 (K092461)United States Endoscopy Group, Inc.2009-11-05
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K093187)Avantis Medical Systems, Inc.2009-11-05
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A (K092359)Cook Ireland, Ltd.2009-11-02
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L (K092309)Olympus Medical Systems Corporation2009-10-30
PALINDROME P HEMODIALYSIS CATHETER (K092205)Covidien Lp, Formerly Registered AS Kendall2009-10-30
SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 (K092342)The Smartpill Corporation2009-10-30
ENTRACARE GASTROSTOMY FEEDING TUBE (K092418)Entracare, LLC2009-10-23
CLEARPATH (K091305)Easyglide , Ltd.2009-10-23
COLONIC SPLINTING OVERTUBE, MODEL 00711145 (K092221)United States Endoscopy Group, Inc.2009-10-20
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR (K091516)Well Lead Medical Co., Ltd.2009-10-16
CAD 12, COLONOSCOPY ASSIST DEVICE (K092156)Softscope Medical Technologies, Inc.2009-10-14
3 WAY SILICONE FOLEY BALLOON CATHETER (K091767)Cook Urological, Inc.2009-10-09
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT (K092049)Sainath Intellectual Properties, LLC2009-10-09
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 (K091962)Lumenis, Inc.2009-09-30
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (K091637)Corpak Medsystems2009-09-29
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 (K091697)Transenterix, Inc.2009-09-28
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM (K090557)Given Imaging , Ltd.2009-09-28
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (K083840)Msi Medserv International Deutschland GmbH2009-09-28
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (K090183)Cook Endoscopy2009-09-25
RP CUTTING NEEDLE (K092059)Riverpoint Medical2009-09-24
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB (K091930)Anchor Products Co.2009-09-23
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H (K091759)Olympus Medical Systems Corporation2009-09-18
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM (K081996)Flexible Stenting Solutions, Inc.2009-09-15
ESTECH HAWKEYE INTRODUCER SYSTEMS (K091350)Endoscopic Technologies, Inc. D/B/A Estech2009-09-15
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (K091968)KARL STORZ Endoscopy-America, Inc.2009-09-14
EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS (K091211)Ethicon Endo-Sugery, LLC2009-09-04
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A (K091495)Olympus Medical Systems Corporation2009-09-03
SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS (K091869)Covidien Lp, Formerly Registered AS United States2009-09-01
DIRECTVISION GUIDE SYSTEM (K091600)Percuvision, LLC2009-08-25
AMSURE PVC INTERMITTENT CATHETER (K091306)Amsino International, Inc.2009-08-21
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, (K090960)Hollister, Inc.2009-08-20
FOOTPRINT URINARY DRAINAGE CATHETER (K090576)Footprint Medical2009-08-12
AMSURE HYDROPHILIC LATEX FOLEY CATHETER (K091699)Amsino International, Inc.2009-08-10
FUJINON STERILE OVERTUBES (K091773)Fujinon, Inc.2009-08-07
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A (K090002)Baxter Healthcare Corp2009-08-07
NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 (K091648)Conmed Integrated Systems (Cmis)2009-08-05
BULLSEYE BILIARY STENT SYSTEM (K082093)Squareone2009-07-29
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM (K090210)Olympus Medical Systems Corporation2009-07-29
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT (K091405)Given Imaging , Ltd.2009-07-29
HAEMOBAND MULTI-LIGATOR (K091519)Haemoband Surgical, Ltd.2009-07-28
PLS PORTABLE LIGHT SOURCE (K091829)Optim, Inc.2009-07-28
SONOLITH I-SYS LITHOTRIPER (K083614)Technomed Medical Systems, SA2009-07-27
INSUFLOW CO2IONSHIELD (K090879)Lexion Medical, LLC2009-07-23
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER (K091832)Endogastric Solutions, Inc.2009-07-22
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 (K090485)Percutaneous Systems, Incorporated2009-07-22
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 (K090902)Transenterix, Inc.2009-07-22
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 (K091355)Conmed Endoscopic Technologies, Inc.2009-07-22
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP (K090830)Laborie Medical Technologies, Ltd.2009-07-21
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) (K091760)Dermaport, Inc.2009-07-20
NUTRAC PELVATOR, MODEL PEL 200 (K083704)Verity Scientific , Ltd.2009-07-14
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K083712)Dipure, LLC2009-07-10
SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM (K091515)Novadaq Technologies, Inc.2009-07-09
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM (K091783)Avantis Medical Systems, Inc.2009-07-07
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