meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
49
Latest Decision
1986-10-02

Clearances · page 94 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K863697 MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA Shiley, Inc. LFJ Class II 1986-10-02
K861599 T-FASTENER Medi-Tech, Inc. KNT Class II 1986-10-02
K863471 COLORADO MEDICAL MODEL PTC 1000 Colorado Medical, Inc. KXM Class II 1986-10-02
K862840 GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N Gambro, Inc. FJG Class II 1986-09-29
K863592 DISSCAP 80E, 110E, 140E, 160E Hospal Medical Corp. FJI Class II 1986-09-25
K863297 MODIFICATION'S TO TORAY'S B-2 SERIES National Medical Care, Medical Products Div., Inc. FJT Class II 1986-09-25
K863496 MEDIFLEX TRANSDUCER PROTECTOR Mediflex Intl. FIB Class II 1986-09-23
K861959 BMRI SOFT TISSUE BIOPSY NEEDLE Bio-Medical Resources, Inc. KNW Class II 1986-09-23
K862573 HOLLISTER DRAIN TUBE ATTACHMENT Hollister, Inc. KNT Class II 1986-09-23
K862580 NEPHROSTOMY DRAINAGE KIT (A-150) Advanced Clinical Products, Inc. KNX Class II 1986-09-23
K862489 ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE Knight Medical, Inc. KNT Class II 1986-09-23
K861156 HOSPAL DIALYSATE FOR CAVHD Hospal Medical Corp. KPO Class II 1986-09-23
K862581 NEPHROSTOMY CONNECTING TUBE (A-50) Advanced Clinical Products, Inc. KNX Class II 1986-09-23
K862424 STEERABLE CATHETER SYSTEM Endovations GCP Class II 1986-09-22
K862551 FUNS-10, FUNS-11 Reichert-Jung, Inc. FGB Class II 1986-09-12
K862536 MODEL 1010 AMBULATORY PH MONITORING SYSTEM Oxford Medilog, Inc. FFT Class I 1986-09-12
K862107 PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR Penn Medical Devices, Inc. ODC Class II 1986-09-11
K862539 SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE Mentor Corp. FAD Class II 1986-09-09
K862716 HEMOFILTRATION SYSTEM 10 Gambro, Inc. FII Class II 1986-09-09
K863169 MODEL AS-72 ADMINISTRATION SET Life-Tech Intl., Inc. FAP Class II 1986-09-09
K863128 PERITONEAL DIALYSIS CATHETERS Thermedics, Inc. FJS Class II 1986-09-09
K862304 DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM Cd Medical, Inc. FKQ Class II 1986-09-09
K862484 HCI Y-CONNECTOR Hospital Concepts, Inc. KOD Class II 1986-09-09
K862327 MODEL RCV REFLUX CHECK VALVE Life-Tech Intl., Inc. FAP Class II 1986-09-04
K862251 MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE Bio-Flow, Inc. KNX Class II 1986-09-04
K860325 PRISTINE CULTURE CATHETER Hall/Mccollum Laboratories, Inc. KOD Class II 1986-08-19
K862934 HOLLISTER FEMALE URINARY COLLECTION POUCH Hollister, Inc. KNX Class II 1986-08-19
K861494 EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML Polymer Technologies KNT Class II 1986-08-18
K862124 POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER Polymed Laboratories KOD Class II 1986-08-14
K862091 MCGAW NUTRA-FEED EFS ENTERAL FEEDING TUBE Kendall Mcgaw Laboratories, Inc. KNT Class II 1986-08-14
K862000 KEYMED FLEXIBLE ESOPHAGEAL DILATORS Keymed, Inc. KNQ Class II 1986-08-12
K862058 RAPID ENDOSCOPIC LAVAGE SYSTEM Endovations OCX Class II 1986-08-11
K862722 TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE Mercury Enterprises, Inc. FKY Class II 1986-08-11
K861862 DIETO CONTAINER FOR ENTERAL NUTRITION Gil-Med Industries C/O Kegan & Kegan, Ltd. KNT Class II 1986-08-11
K861863 MODIFIED PROTECTIVE GARMENT Procter & Gamble Mfg. Co. EYQ Class I 1986-08-11
K861646 BIO-CARB D16000, D16001, AND D17000 Societe D' Analyses Bio-Pharmaceutiques,Inc. FJH Class II 1986-08-07
K862771 MEDCOMP C.A.V.H. CATHETER Medical Components, Inc. LFK Class II 1986-08-06
K862717 HAND MIRROR (ENDOSCOPE) Simpson/Basye, Inc. GCO Class II 1986-07-30
K862380 MATTRESS COVER Intera Corp. EYQ Class I 1986-07-28
K862611 STERILE DISPOSABLE TROCAR-SLEEVE DEVICES United States Surgical, A Division of Tyco Healthc GCJ Class II 1986-07-23
K860593 ET/RT PAPILLOTOME Hobbs Medical, Inc. KNS Class II 1986-07-22
K862693 TORAY FILTRYZER DIALYZER, B1-2.0. National Medical Care, Medical Products Div., Inc. FJI Class II 1986-07-22
K862015 O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER Bipore, Inc. FIB Class II 1986-07-22
K861427 ENTUBE TM, ENTERAL FEEDING TUBE Entech, Inc. KNT Class II 1986-07-18
K861618 TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024) Travenol Laboratories, S.A. KNT Class II 1986-07-15
K861537 ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5 National Medical Care, Medical Products Div., Inc. FJI Class II 1986-07-10
K861536 ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 National Medical Care, Medical Products Div., Inc. FJI Class II 1986-07-10
K861916 ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER National Medical Care, Medical Products Div., Inc. FJI Class II 1986-07-10
K861472 MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 National Medical Care, Medical Products Div., Inc. FKQ Class II 1986-07-10
K862060 POLYPECTOMY SNARE Endovations KNS Class II 1986-06-27
K862002 MEDISYSTEMS PHERESIS NEEDLE Medisystems Corp. FIE Class II 1986-06-27
K853555 FAST FORMALERT Organon Teknika Corp. KOC Class II 1986-06-26
K862046 SWAN-NECK PERITONEAL DIALYSIS CATHETERS Accurate Surgical Instruments Co. FJS Class II 1986-06-19
K861776 HIGH EFFICIENCY HEMODIALYSIS SYSTEM Travenol Laboratories, S.A. KDI Class II 1986-06-19
K861468 IMPAX, MALE IMPOTENCE AID Lehigh Group LKY Class II 1986-06-18
K861090 NUTRI-CATH - FEEDING TUBE Gesco Intl., Inc. KNT Class II 1986-06-18
K860704 THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND Keymed, Inc. NZA Class II 1986-06-17
K861070 COLOPLAST CONVEX RING Coloplast A/S EXB Class I 1986-06-16
K861552 TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS Entech, Inc. KNT Class II 1986-06-16
K861017 GALENICA'S DISPOSABLE ANOSCOPES Galenica Enterprises, Inc. FER Class II 1986-06-13
K861220 LUNDERQUIST - RING PTC DRAINAGE CATHETER Meadox Surgimed, Inc. FGE Class II 1986-05-19
K861478 BARD DOUBLE PIGTAIL URETERAL STENT C.R. Bard, Inc. FAD Class II 1986-05-15
K861469 DUTHOY STONE BASKET Lake Region Mfg., Inc. FFL Class II 1986-05-15
K860818 ONE TIME ENTERAL FEEDING BAG Acme United Corp. KNT Class II 1986-05-15
K860863 ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER George Percy Mcgown LQC Class II 1986-05-15
K860943 JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) Colon Therapeutics KPL Class II 1986-05-15
K855176 TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS Urologic Surgical Devices Corp. FBK Class II 1986-05-13
K860990 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY Endovations FGE Class II 1986-05-13
K852359 AMUCHINA/DIALYZER DISINFECTANT Amuchina Intl., Inc. FKQ Class II 1986-05-13
K860997 GASTROINTESTINAL CYTOLOGY BRUSH Endovations FDX Class II 1986-05-02
K860991 SCLEROTHERAPY INJECTION CATHETER Endovations KNT Class II 1986-05-02
K860362 SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER Travenol Laboratories, S.A. KNX Class II 1986-04-29
K861230 MONITRAL S Hospal Medical Corp. FKP Class II 1986-04-25
K854821 MMG EXTERNAL FEMALE CATHETERS Medical Technologies of Georgia KNX Class II 1986-04-24
K861192 GENTLE BACK, PLASTIC URINARY DRAINAGE BAG Advanced Clinical Products, Inc. KNX Class II 1986-04-23
K861174 SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA Shiley, Inc. LFJ Class II 1986-04-23
K860368 URDYN 5000 (UROFLOWMETER) Dantec Electronics, Inc. FFO Class I 1986-04-23
K860771 VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE Van-Tec, Inc. GCQ Class II 1986-04-23
K861200 UROTOPO CATHETER Houston Biomedical, Inc. KOD Class II 1986-04-23
K860822 LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35 Cooper Lasersonics, Inc. FAJ Class II 1986-04-17
K861251 AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N American Medical Products, Inc. KNX Class II 1986-04-17
K855019 DURAHESIVE PROTECTIVE BARRIER WIPE Convatec, A Division of E.R. Squibb & Sons EXB Class I 1986-04-16
K860810 MEDCOMP'S FEMORAL VEIN CATHETERS Medical Components, Inc. LFK Class II 1986-04-08
K854773 SUPERCATH A.V. FISTULA Togo Medikit Co., Ltd. FIE Class II 1986-04-08
K855098 COMPAT ENTERAL DELIVERY SYSTEMS Sandoz Nutrition KNT Class II 1986-04-08
K861181 NORTA TEFLON COATED LATEX BALLOON CATHETERS Beiersdorf, Inc. KOD Class II 1986-04-08
K855097 COMPAT ENTERAL DELIVERY SYSTEMS Sandoz Nutrition KNT Class II 1986-04-08
K860700 CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 Travenol Laboratories, S.A. KDJ Class II 1986-04-07
K860589 INFLATOR/DEFLATOR PISTON SYRINGE Microvasive KNT Class II 1986-04-07
K861106 FRESENIUS HEMOFLOW F80 DIALYZER Seratronics, Inc. KDI Class II 1986-04-07
K860265 TELESCOPE PROTECTION TUBE R. J. Ltd., Ind. KOD Class II 1986-04-07
K860366 CHALLENGER HOT BIOPSY FORCEPS Microvasive KNS Class II 1986-04-07
K860938 GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS Gambro, Inc. KDI Class II 1986-04-07
K860674 DRS-4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. LIF Class II 1986-04-07
K860094 HURWITZ DIALYSIS CATHETER Gish Biomedical, Inc. LFJ Class II 1986-04-07
K860267 MARDIS DANGLER URETERAL STENT SET Van-Tec, Inc. FAD Class II 1986-04-03
K860268 VAN-TEC DEFLECTING GRASPING FORCEPS Van-Tec, Inc. FFL Class II 1986-04-03
K860946 DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER Van-Tec, Inc. FFL Class II 1986-04-03
K861051 ISOLIFE DISPENSING SYSTEM Navaco Laboratories KNT Class II 1986-04-03
K860246 ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE Buckman Co., Inc. PUP Class II 1986-04-02

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