meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
41
Latest Decision
1986-03-25

Clearances · page 95 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K860269 VAN-TEC DEFLECTING LOOP RETRIEVER Van-Tec, Inc. FFL Class II 1986-03-25
K860337 VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. Van-Tec, Inc. KOD Class II 1986-03-25
K860270 VAN-TEC DEFLECTING ROTATING SEGURA BASKET Van-Tec, Inc. FFL Class II 1986-03-25
K860571 F.M. WEIST,KG (URODYNAMIC SYSTEMS) F.M. Wiest USA, Inc. FAP Class II 1986-03-18
K860789 JMD AV FISTULA NEEDLE (MODIFICATION) Jms Co., Ltd. FIE Class II 1986-03-18
K854908 UROFLEX Angiomed U.S., Inc. FAD Class II 1986-03-14
K860026 ULTRAMAX III, DIALYZER REPROCESSING DEVICE Medicorp, Inc. LIF Class II 1986-03-14
K860740 ERIKA ARTERIAL LINE 03-9625-9 National Medical Care, Medical Products Div., Inc. FJK Class II 1986-03-14
K860441 ENTROKIT WITH MAGLINTE CATHETER Lafayette Pharmacal, Inc. KGC Class II 1986-03-12
K855076 ANGIOMED URETER DIATION SETS Angiomed U.S., Inc. KOD Class II 1986-03-11
K860599 ETHOX LAVAGE TUBE Ethox Corp. KDH Class II 1986-03-11
K860517 MENTOR CORPORAL DILATORS Mentor Corp. FAE Class II 1986-03-11
K860055 MENTOR SINGLE COIL URINARY DIVERSION STENT SET Mentor Corp. FAD Class II 1986-03-11
K855142 ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY Angiomed U.S., Inc. FGE Class II 1986-03-11
K860484 CURITY & KENGUARD SILICONE COATED FOLEY CATHETER The Kendal Co. KOD Class II 1986-03-11
K855143 ANGIOMED EXCHANGE DRAINAGE CATHETER SETS Angiomed U.S., Inc. KOD Class II 1986-03-11
K860598 MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS Procter & Gamble Mfg. Co. EYQ Class I 1986-03-05
K860266 ELLIK EVACUATOR R. J. Ltd., Ind. KQT Class II 1986-03-05
K860336 HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS Breem Laboratories FKQ Class II 1986-03-04
K860296 HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES Physicians Surgeons Purchasing Group FKQ Class II 1986-03-04
K860515 DUAL LUMEN NEEDLE (PRODUCT CHANGE) Quinton, Inc. LBW Class II 1986-03-04
K860297 HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES Renal Hygienics FKQ Class II 1986-03-04
K854625 UROTEC CLOSED IRRIGATIION SYRINGE Urotec Systems Corp. KOD Class II 1986-03-04
K860449 MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE Top Corp. FIE Class II 1986-02-26
K860459 UNITY DISPOSABLE INCONTINENT BRIEF Bevan Medical, Inc. EYQ Class I 1986-02-26
K854726 MEDI-WIPES UNITED ANTISEPTIC SKIN PREP Pfizer, Inc. EXB Class I 1986-02-24
K855140 ANGIOMED RENAL DILATION SET Angiomed U.S., Inc. KOD Class II 1986-02-24
K854514 AMBI-24 PH/PRESSURE MONITOR Biosearch Medical Products, Inc. FFT Class I 1986-02-24
K855151 FRITCH OPHTHALMIC ENDOSCOPE Regtec GDB Class II 1986-02-19
K860155 PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 Medical Components, Inc. FKO Class II 1986-02-14
K860103 MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE Endotherapeutics GCP Class II 1986-02-12
K860102 MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE Endotherapeutics FHP Class II 1986-02-12
K860285 XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE Vygon Corp. KNT Class II 1986-02-11
K855003 BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732 Travenol Laboratories, S.A. KNW Class II 1986-02-10
K854862 CURITY URETERAL STENT The Kendal Co. FAD Class II 1986-02-10
K860040 HYDRAJUST III UROLOGICAL TABLE Mallinckrodt Group, Inc. KQS Class I 1986-02-10
K854652 ANGIOMED URETERAL STONE DISLODGERS Angiomed U.S., Inc. FFL Class II 1986-02-10
K854730 DAISY (ABSORBENT INCONTINENCE SHIELD) Lic-Orthion EYQ Class I 1986-02-06
K860052 QWIK-CALL Emde Corp. KNT Class II 1986-02-06
K854729 ADAM (ABSORBENT INCONTINENCE SHIELD) Lic-Orthion EYQ Class I 1986-02-06
K860241 JMS AV FISTULA NEEDLE Jms Co., Ltd. FIE Class II 1986-02-05
K860230 CAPD TRANSFER SET SPIKE 5C4363 Travenol Laboratories, S.A. KDJ Class II 1986-02-05
K852955 HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD Renalchem, Inc. KPO Class II 1986-02-05
K855018 DURAHESIVE WAFER WITH FLANGE Convatec, A Division of E.R. Squibb & Sons EXB Class I 1986-02-04
K854539 UROSTAT Urologics, Inc. KPN Class II 1986-02-04
K855251 MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS Advocacy International, Ltd. KDI Class II 1986-02-04
K854616 ENTERAL FEEDING BAG Medovations, Inc. KNT Class II 1986-01-23
K860075 DYNAFEED ENTERAL PUMP FEED BAG Medline Industries, Inc. KNT Class II 1986-01-23
K855001 FRESENIUS HEMODIALYSIS MACHINE A1008 BSM Seratronics, Inc. FLC Class II 1986-01-21
K854660 THE MMG ENTERAL FEEDING ADMINISTRATION SET Medical Technologies of Georgia KNT Class II 1986-01-21
K853585 OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS Olympus Corp. FET Class II 1986-01-21
K855212 ASAHI AM SERIES DIALYZERS Advocacy International, Ltd. FJI Class II 1986-01-21
K855077 ANGIOMED HARZMANN DISCS Angiomed U.S., Inc. KOD Class II 1986-01-21
K852642 CENTRAL VEIN CATHETERIZATION TRAY Teleflexmedical, Inc. FDZ Class I 1986-01-16
K852471 CONFIDENT ODOR ELIMINATOR Hallmark Industries, Inc. EXB Class I 1986-01-14
K853059 LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE Tridak Division of Indicon, Inc. FAP Class II 1986-01-10
K853683 UMS-100 Narco Bio-Systems FAP Class II 1986-01-10
K855209 NIR LAT MALE EXTERNAL CATHETER Mali, Inc. KNX Class II 1986-01-10
K854966 ACUTE PERITONEAL DIALYSIS CATHETERS Thermedics, Inc. FKO Class II 1986-01-09
K854443 O'NEIL URINARY CATHETER INTRODUCER Pennine Medical , Ltd. KOD Class II 1986-01-08
K854951 PLUME Y SET Hospal Medical Corp. FIE Class II 1986-01-08
K854391 HEMODIALYSIS CONCENTRATE Dana Laboratories FKQ Class II 1986-01-08
K855121 COLOSHIELD KIT Deknatel, Inc. KNT Class II 1986-01-08
K853406 GAMBRO LUNDIA PRO 3 & 5 DIALYZER Gambro, Inc. FJG Class II 1986-01-08
K854612 ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 Med-West, Inc. LFK Class II 1986-01-03
K854614 LONG TERM PERITONEAL CATHETER Thermadics, Inc. FJS Class II 1985-12-19
K851962 ZIMMON BILIARY STENT SET Wilson-Cook Medical, Inc. FGE Class II 1985-12-17
K851954 PVL-4.8-200 BALLOON STONE EXTRACTOR Wilson-Cook Medical, Inc. FGE Class II 1985-12-17
K854367 HD-SECURA HEMADIALYSIS MACHINE Organon Teknika Corp. FKP Class II 1985-12-16
K854479 BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH Nipro Company, Ltd. FKP Class II 1985-12-16
K854280 CLIRANS TAF HOLLOW FIBER DIALYZER Terumo Medical Corp. FJI Class II 1985-12-13
K854586 HOLLOW FIBER DIALYZER Travenol Laboratories, S.A. KDI Class II 1985-12-13
K854580 CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH Coloplast A/S KNX Class II 1985-12-13
K854309 GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 Gambro, Inc. KDI Class II 1985-12-13
K853936 1351 UROFLOW AUTO START Life-Tech Intl., Inc. FAP Class II 1985-12-02
K854215 DYNAFEED Medline Industries, Inc. KNT Class II 1985-12-02
K854575 MODIFIED AM-SERIES DIALYZERS Asahi Medical Co., Ltd. FJI Class II 1985-12-02
K854512 TUBING CLAMP CAT#1000-A Rao Medical Devices, Inc. FKK Class I 1985-12-02
K854378 DEPEND FITTED BRIEF Kimberly-Clark Corp. EYQ Class I 1985-12-02
K853280 FOUR CHANNEL PH PROBE Akron City Hospital FFT Class I 1985-12-02
K854517 NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET Travenol Laboratories, S.A. FKK Class I 1985-12-02
K853892 VISTA MED-URISTAT Vista Med KNX Class II 1985-12-02
K854404 ROTEX SCREW BIOPSY NEEDLE Meadox Surgimed, Inc. FCG Class II 1985-12-02
K854291 MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY Medsurg Industries, Inc. KNW Class II 1985-11-26
K854297 MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM Medsurg Industries, Inc. KNW Class II 1985-11-26
K854289 MEDSURG ULTRASOUND BIOPSY TRAY Medsurg Industries, Inc. FCG Class II 1985-11-26
K854408 ADULT ABSORBENT INCONTINENT BRIEF Weyerhaeuser Co. EYQ Class I 1985-11-19
K854480 URINARY DRAINAGE BAG The West Co., Inc. KNX Class II 1985-11-19
K853648 SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO Synectics-Dantec FFT Class I 1985-11-18
K853851 FRESENIUS DISPOSABLE BLOOD LINES Seratronics, Inc. FJK Class II 1985-11-12
K854084 PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT Organon Teknika Corp. FKL Class II 1985-11-08
K853513 DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY Cd Medical, Inc. FKP Class II 1985-11-06
K854011 RENALFO HEMOFILTER CAVHD Renal Systems, Inc. KDI Class II 1985-11-05
K853384 E-Z-EM GASTRIC LAVAGE CATHETER E-Z-Em, Inc. KNT Class II 1985-11-05
K853253 CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI Corpak Co. KNT Class II 1985-11-05
K853666 ENDODYNAMICS SIEGEL THERAPUTIC STENT E-Z-Em, Inc. FGE Class II 1985-11-05
K854271 ASA BLOOD TUBING LINES Organon Teknika Corp. FJK Class II 1985-11-05
K852490 URI-CATH SYSTEM Gesco Intl., Inc. KNX Class II 1985-11-05
K853680 ENDODYNAMIC SIEGEL SPHINCTEROTOME E-Z-Em, Inc. KNS Class II 1985-11-04
K854173 UCD URINE SPECIMEN COLLECTOR Baker Instructions Corp. KNX Class II 1985-11-04

11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.