meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
46
Latest Decision
1977-04-15

Clearances · page 113 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K770578 PARALLEL PLATE DIALYZER Cobe Laboratories, Inc. FJG Class II 1977-04-15
K770482 CATHETER, SINGLE PUNCTURE Y Mdl Medical Device Laboratories, Inc. KOC Class II 1977-04-15
K770280 CORD, ELECTROSURGICAL-STERILE & DISPOS. V. Mueller O.V. Baxter Healthcare Corp. KNS Class II 1977-04-15
K770524 TRANSDUCER PROTECTOR, RT-901, RT-902 Renal Systems, Inc. KOC Class II 1977-03-30
K770552 CATHETER, KIDNEY DIALYSIS, HEMO-CATH II Medical Disposables Intl., Inc. KOC Class II 1977-03-30
K770516 MEMBRANE SOURCE-EX SERIES DIALYZER CART. Extracorporeal Medical Specialities, Inc. KNX Class II 1977-03-30
K770300 COLON IRRIGATION DEV.,COLON-A-SUN COLONI Sun Product Dist., Inc. FCE Class I 1977-03-30
K770557 DRAINAGE BAG, 4000 ML. Concord Laboratories, Inc. KNX Class II 1977-03-24
K770562 HANDLER CATHETER Janet Beach, Ltd. KOD Class II 1977-03-24
K770493 TRAVACATH Travenol Laboratories, S.A. KOD Class II 1977-03-21
K770497 DRAINAGE UNIT, COMBINATION Concord Laboratories, Inc. KNX Class II 1977-03-21
K770490 DRAINAGE BAG, IMPROVED, FLAT Pharmaseal Div., Baxter Healthcare Corp. KNX Class II 1977-03-21
K770489 CATHETER WITH HARD VALVE Pharmaseal Div., Baxter Healthcare Corp. KOD Class II 1977-03-21
K770496 UNIVERSAL TRAY Concord Laboratories, Inc. FCM Class II 1977-03-21
K770475 PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2 Travenol Laboratories, S.A. KOC Class II 1977-03-16
K770299 TYGON M-60/TYGON M-70 Norton Performance Plastics Corp. FID Class II 1977-03-16
K770320 URINARY DRAINAGE SET, CLOSED, STERILE Medical Devices, Inc. KNX Class II 1977-03-16
K770408 KARAYA GUM POWDER, OSTOMY Howmedica Corp. EZK Class II 1977-03-15
K770399 VALVE FOR CLOSED SYS. URINARY DRAINAGE Will Ross Co. KNX Class II 1977-03-09
K770248 ARGYLE RAPID GASTRIC LAVAGE KIT Sherwood Medical Industries KDH Class II 1977-03-09
K770350 DIALYSIS DELIVERY SYS., ULTIM. MODEL II Vital Systems, Inc. FKP Class II 1977-03-08
K770382 NEEDLE, FISTULA, ERIKA Erika, Inc. KOC Class II 1977-03-08
K770348 TROCAR SLEEVE SYSTEM, EXTENDED Richard Wolf Medical Instruments Corp. GCJ Class II 1977-03-08
K770383 STOPCOCK, ONE WAY Cobe Laboratories, Inc. KOC Class II 1977-03-07
K761340 OSTOMY KARAYA GUM POWDER Howmedica Corp. EZR Class I 1977-03-07
K760047 TRAY, BLADDER IRRIGATION M-C Ind., Inc. EYN Class II 1977-03-01
K760048 TRAY, URETHRAL CATHETERIZATION M-C Ind., Inc. FCM Class II 1977-03-01
K760810 TUBE, GASTRO-ENTEROSTOMY Sherwood Medical Industries EXD Class II 1977-02-28
K770230 KARAYA GUM POWDER Atlantic Surgical EZR Class I 1977-02-28
K770251 SUPER X ADJUSTRETTE Qualitone EXD Class II 1977-02-28
K761229 ANAL/RECTAL SYRINGE Ace Orthopedic Manufacturing Co. KOA Class I 1977-02-24
K770263 DIALYSATE METER RS-2100A, CIRCUIT CHANGE Renal Systems, Inc. FLB Class II 1977-02-18
K770291 SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 Welch Allyn, Inc. FAM Class II 1977-02-18
K770256 CATHETERS, SILICONE COATED Pharmaseal Div., Baxter Healthcare Corp. KOD Class II 1977-02-17
K760556 IRRIGATION CATHETER Sherwood Medical Industries KDH Class II 1977-02-17
K761319 KARAYA GUM PRODUCTS - PROCESS CHANGE Howmedica Corp. EZR Class I 1977-02-15
K770213 BARIOR Tri-Med, Inc. KOC Class II 1977-02-07
K770137 NEGATIVE PRESSURE ADAPTER 5M1350 Travenol Laboratories, S.A. FIL Class II 1977-02-01
K770178 STOMA BAGS W/MICROPOROUS ADHESIVE Hollister, Inc. EXB Class I 1977-02-01
K761083 BARD URINE METER W/ BAG C.R. Bard, Inc. EXR Class II 1977-01-26
K760927 STOMA SHIELD ADAPTER Rudolfo T. Sanchez EXE Class I 1977-01-26
K770122 PROSTATE BIOPSY NEEDLE Cook, Inc. KNW Class II 1977-01-26
K770044 DNC 141 VINCA-FLO Sorensen Research KOC Class II 1977-01-14
K770046 DNC 142 VINCA-FLO Sorensen Research KOC Class II 1977-01-14
K770048 DNC 162 VINCA-FLO Sorensen Research KOC Class II 1977-01-14
K770045 DNC 152 VINCA-FLO Sorensen Research KOC Class II 1977-01-14
K770043 DNC 161 VINCA-FLO Sorensen Research KOC Class II 1977-01-14
K770047 DNC 151 VINCA-FLO Sorensen Research FJT Class II 1977-01-14
K760777 COLON-X Carlton Hygienics, Inc. FCE Class I 1977-01-13
K761007 ARTIFICIAL KIDNEY, C-DAK CORDIS DOW Cordis Corp. FJI Class II 1977-01-12
K760973 HEMODIALYSIS CANNULA & FEMORAL CLAMP Rodell Medical, Inc. FIQ Class II 1977-01-12
K761360 8 LATEX EXTENSION TUBE WITH CONNECTOR Intermed, Inc. KNX Class II 1977-01-10
K761326 ARTERIOVENOUS BLOOD TUBING SETS Extracorporeal Medical Specialities, Inc. FJK Class II 1977-01-10
K761358 COIL DIALYZER MODEL ALT 140 Bentley Laboratories, Inc. FHS Class II 1977-01-10
K760994 MONITOR LINE W/FILTER & NEEDLE Dravon Medical, Inc. KOC Class II 1977-01-06
K760995 DECOLLATING TRAY Dravon Medical, Inc. FJZ Class II 1977-01-06
K761180 SIGMOIDOSCOPE/ DISPOSABLE Smithkline Diagnostics, Inc. FAM Class II 1977-01-05
K761287 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY Travenol Laboratories, S.A. FKP Class II 1977-01-03
K761050 HEPARIN PUMP Dws, Inc. FIR Class II 1976-12-30
K761051 BI-FLOW NEEDLE Dws, Inc. KOC Class II 1976-12-30
K761242 TEFLON COATED RESECTOSCOPE SHEATH V. Mueller O.V. Baxter Healthcare Corp. FJL Class II 1976-12-16
K761145 RADIOISOTOPE CALIBRATOR (CRCO-22NB) G.D. Searle and Co. KPI Class II 1976-12-16
K760522 TABLE, UROSURGICAL Mallinckrodt Group, Inc. KQS Class I 1976-12-16
K760886 RECTAL TUBE DEVICE Van Sickle Plastics Co. EXB Class I 1976-12-09
K761167 ENEMA KIT American Hospital Supply Corp. FCE Class I 1976-12-09
K761081 SINGLE NEEDLE HEMODIALYSIS (BFC-161) Sorensen Research KOC Class II 1976-12-06
K761144 FEM CATH (URETHRAL CATHETER) Mallinckrodt Critical Care KOD Class II 1976-12-06
K760858 RUTNER UNIVERSAL WEDGE CATHETER Cook, Inc. KOD Class II 1976-12-06
K760965 BEDSIDE CONSOLES (11-3-910 & 11-3-930) Seattle Artificial Kidney Supply Co. FKQ Class II 1976-12-06
K761038 SINGLE NEEDLE HEMODIALYSIS Sorensen Research KOC Class II 1976-12-06
K761078 HEMO-CATH I, KIDNEY DIALYSIS CATHETER Medical Disposables Intl., Inc. KOC Class II 1976-12-06
K761082 SINGLE NEEDLE HEMODIALYSIS (BFC-142) Sorensen Research KOC Class II 1976-12-06
K760273 LITHOTRITE V. Mueller O.V. Baxter Healthcare Corp. FGK Class II 1976-12-06
K760647 ADAPTER, FIBER OPTICS HEADLIGHT Pilling Co. FCW Class II 1976-12-06
K760781 TRIEX-1 HOLLOW FIBER DIALYZER Extracorporeal Medical Specialities, Inc. FJT Class II 1976-12-06
K760184 ELEMENT, WORKING V. Mueller O.V. Baxter Healthcare Corp. FDC Class II 1976-12-02
K760183 OBTURATOR, DEFLECTING V. Mueller O.V. Baxter Healthcare Corp. FEC Class II 1976-12-02
K760878 BONGORT ILEOSTOMY POUCH Howmedica Corp. EXB Class I 1976-12-02
K761039 URINARY LEG BAG DRAINAGE TUBE Pharmaseal Div., Baxter Healthcare Corp. KNX Class II 1976-12-02
K761059 MALE URINARY CATHETER, EXTERNAL Intermed, Inc. KOD Class II 1976-12-02
K760172 OBTURATOR, VISUAL V. Mueller O.V. Baxter Healthcare Corp. FEC Class II 1976-12-02
K760180 FORCEPS, GRASPING V. Mueller O.V. Baxter Healthcare Corp. OCZ Class II 1976-12-02
K760182 SHEATH, RESECTOSCOPE V. Mueller O.V. Baxter Healthcare Corp. FDC Class II 1976-12-02
K760189 STOPCOCK, WATERLINE V. Mueller O.V. Baxter Healthcare Corp. FAJ Class II 1976-12-02
K760173 BRIDGE, SHORT DEFLECTING V. Mueller O.V. Baxter Healthcare Corp. FAM Class II 1976-12-02
K760179 SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR V. Mueller O.V. Baxter Healthcare Corp. FAJ Class II 1976-12-02
K760761 ESOPHAGEAL MOTILITY TUBE Sherwood Medical Industries FFX Class II 1976-11-30
K760708 SILASTIC BRAND Q7-2091 GASTRIC SUMP TUBE Dow Corning Corp. Healthcare Industries Materials KNT Class II 1976-11-23
K760945 SILASTIC PERCUTANEOUS GASTROINTEST. TUBE Dow Corning Corp. Healthcare Industries Materials KNT Class II 1976-11-23
K760943 SILASTIC BRAND GASTRIC LAVAGE TUBE Dow Corning Corp. Healthcare Industries Materials KNY Class II 1976-11-23
K760860 SILASTIC ILEAL RESERVOIR CATHETER Dow Corning Corp. Healthcare Industries Materials EXB Class I 1976-11-23
K760935 WINGED FISTULA NEEDLE Gambro, Inc. KOC Class II 1976-11-19
K760922 PERFUSION TUBING SET Shiley, Inc. KDL Class II 1976-11-19
K760702 ERI-FLO 900 DIALYZER Erika, Inc. FHS Class II 1976-11-19
K760868 VEST RESTRAINT Orthopedic Equipment Co., Inc. KNW Class II 1976-11-01
K760374 DIALYZER (MODEL 1850) Erika, Inc. FHS Class II 1976-10-27
K760725 COIL MACHINE ADAPTER Gambro, Inc. FLC Class II 1976-10-27
K760822 MODEL TX-8 PANENDOSCOPE American Cystocope Makers, Inc. FAK Class II 1976-10-21
K760665 FISTULA NEEDLE (#11-265) Cobe Laboratories, Inc. KOC Class II 1976-10-21
K760717 FLEXIBLE BIOPSY FORCEPS V. Mueller O.V. Baxter Healthcare Corp. KOA Class I 1976-10-21

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