meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
43
Latest Decision
1985-11-04

Clearances · page 96 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K853353 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT Superior Healthcare Group, Inc. KNT Class II 1985-11-04
K854206 ULTRACLONE 05-100 GUINEA PIG RBC Earl-Clay Laboratories, Inc. KPO Class II 1985-10-31
K853962 ERIKA ARTERIAL LINE 03-9837-0 National Medical Care, Medical Products Div., Inc. FJK Class II 1985-10-18
K853740 KAY PLUS ADULT DIAPER Beghin_Say Intl., Inc. EYQ Class I 1985-10-17
K852535 E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY Tri-Med Specialties, Inc. KNT Class II 1985-10-17
K853536 VELCRO FISTULA PRESSURE CLAMPS Cp Medical KXM Class II 1985-10-17
K852856 LABORIE URODYNAMICS PROCESSOR Tridak Division of Indicon, Inc. FAP Class II 1985-10-17
K853274 AMERICAN DILATATION SYSTEM American Endoscopy, Inc. KNQ Class II 1985-10-17
K852552 COONS GASTROSTICK SYSTEM Medi-Tech, Inc. KNT Class II 1985-10-17
K853817 COBE REN NEW-D DISPENSING KIT Cobe Laboratories, Inc. LIF Class II 1985-10-17
K853735 COLORADO MEDICAL MODEL CTM-3000 Colorado Medical, Inc. FIZ Class II 1985-10-04
K852293 BARD-PARKER BILIARY BALLOON CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic FGE Class II 1985-10-04
K853288 FEEDING UNITS & TUBES I M, Inc. KNT Class II 1985-10-04
K853530 ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH E-Z-Em, Inc. FDX Class II 1985-10-04
K853550 TRAVENOL CAPD Y SET 5C4354 Travenol Laboratories, S.A. KDJ Class II 1985-10-04
K853514 RIGID ENDOSCOPE American Edwards Laboratories GCM Class II 1985-10-04
K853119 URODYN 1000 Dantec Electronics, Inc. FFO Class I 1985-10-04
K853104 DISPOSABLE, STERILE BIOPSY PUNCH August C. Stiefel Research Institute, Inc. FCI Class II 1985-10-04
K852084 KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP The Kendal Co. KOD Class II 1985-09-20
K853543 DAVOL RETRIEVAL BALLOON CATHETER C.R. Bard, Inc. FGE Class II 1985-09-20
K852764 IDECAP DIALYZER Trans-National Trade Development Corp. FJH Class II 1985-09-20
K852083 THE KENDALL URINARY OUTPUT MONITOR The Kendal Co. FFO Class I 1985-09-20
K844445 REVIVE SYSTEM Revive Systems Corp. LKY Class II 1985-09-17
K853510 MINIFILTER HEMOFILTER Amicon, Inc. KDI Class II 1985-09-12
K853207 PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE American Pharmaseal Div. Ahsc KOD Class II 1985-09-12
K853486 OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE Olympus Corp. FGA Class II 1985-09-12
K851242 GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO Cook, Inc. FGE Class II 1985-09-11
K853591 DIALYZER, CAPILLARY, HOLLOW FIBER Organon Teknika Corp. FJI Class II 1985-09-11
K852749 RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT Mesa Medical, Inc. FKQ Class II 1985-09-10
K852885 FILTRAL HEMODIALYZER Hospal Medical Corp. KDI Class II 1985-09-06
K853413 RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS Alcide Corp. LIF Class II 1985-09-06
K851975 ENTERAL FEEDING BAG, 1000 ML, & TUBING SET Venusa , Ltd. KNT Class II 1985-09-05
K852389 URETERAL STENT American Medical Systems, Inc. FAD Class II 1985-09-05
K853333 DIMENSION TOTAL HIP PROSTHESIS Kirschner Medical Corp. KDI Class II 1985-09-03
K852966 ENTERAL FEEDING CONTAINER Empire Industries, Inc. KNT Class II 1985-08-27
K853309 P.A. ENTERAL FEEDING BAG 1100 Pa Medical Corp. KNT Class II 1985-08-27
K853458 H-H SEXTON SCUP URINE MGMT. SYS Holter-Hausner Intl. KNX Class II 1985-08-27
K852619 URI-SURE Ashai Co. , Ltd. KNX Class II 1985-08-27
K852951 WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS Welch Allyn, Inc. FCW Class II 1985-08-27
K853337 TROCAR/CANNULA/SHEATH SET American Edwards Laboratories KOD Class II 1985-08-23
K852051 EXTERNAL MALE CATHETER Buffalo Medical Specialties Mfg., Inc. KNX Class II 1985-08-22
K853283 VACCESS TM 4006 Vas-Cath of Canada , Ltd. LFJ Class II 1985-08-22
K853197 MIC JEJUNAL FEEDING TUBE Medical Innovations Corp. KNT Class II 1985-08-22
K852874 5F ELECTRODE(LITHOTRIPTOR) Northgate Research, Inc. FFK Class II 1985-08-21
K852324 URETERAL DILATOR American Edwards Laboratories EZN Class II 1985-08-21
K852888 OLYMPUS RIGID URETERORENOSCOPE Olympus Corp. FGB Class II 1985-08-21
K852707 GASTRO-ENTEROSTOMY TUBE Medical Innovations Corp. KNT Class II 1985-08-14
K853079 PROTECTIVE PAD FOR INCONTINENCE I.C.D. Industries, Inc. EYQ Class I 1985-08-09
K852363 MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT Medical Innovations Corp. KNT Class II 1985-08-09
K852793 URETERAL DILATOR/SHEATH SET American Edwards Laboratories EZN Class II 1985-08-09
K850605 RADI-BIOPSY DEVICE Radiplast AB KNW Class II 1985-08-09
K852792 CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW Corpak Co. KNT Class II 1985-08-08
K852287 PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET Cook Ob/Gyn KOB Class II 1985-08-08
K852127 AMSCO URO-ENDO MOBILE TABLE American Sterilizer Co. KQS Class I 1985-08-08
K852200 SIMPLASTIC SUPRA PUBIC CATHETER Franklin Medical USA, Inc. KOB Class II 1985-08-07
K852276 ESTEEM INCONTINENT SYSTEM Bevan Medical, Inc. EYQ Class I 1985-08-07
K852085 KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG The Kendal Co. KNX Class II 1985-08-07
K852014 EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA Effner and Spreine Co. KOA Class I 1985-08-07
K851483 UROBEI STRESS INCONTINENCE MONITOR Browne Medical, Inc. FAP Class II 1985-08-07
K851922 URETERAL STONE DISLODGER Inter-Med Corp. FFL Class II 1985-08-02
K851160 VAN-TEC GUIDE WIRE W/HYDROMER COATING Van-Tec, Inc. KOD Class II 1985-07-29
K852678 CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353 Travenol Laboratories, S.A. KDJ Class II 1985-07-29
K850979 HEMOCONCENTRATOR KIT Omnis Surgical, Inc. KDI Class II 1985-07-29
K850799 RINSE MACHINE KR-4 KIDNEY RINSE-4 Medical Technologies International, Inc. LIF Class II 1985-07-29
K851965 WILSON-COOK STONE EXTRACTOR Wilson-Cook Medical, Inc. FFL Class II 1985-07-29
K851960 SOEHENDRA BILIARY DILATING CATHETER-SBDC-7 Wilson-Cook Medical, Inc. FGE Class II 1985-07-29
K852605 BLOOD TUBING SET Medflex International, Inc. FJK Class II 1985-07-29
K852309 ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 Erika, Inc. FJK Class II 1985-07-26
K852310 NATURALYTE BICARBONATE CONCENTRATE-DRY PACK Erika, Inc. FKQ Class II 1985-07-26
K850214 STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN Accurate Surgical Instruments Co. FJS Class II 1985-07-26
K851236 HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES Infarkem Corp. FJK Class II 1985-07-26
K851952 VARICES INJECTOR Wilson-Cook Medical, Inc. FBK Class II 1985-07-26
K852251 FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40 Seratronics, Inc. KDI Class II 1985-07-25
K851958 ROTATABLE POLYPECTOMY SNARE POS-1 Wilson-Cook Medical, Inc. KNS Class II 1985-07-25
K852289 MODEL SA3 ESOPHAGEAL PH ELECTRODE World Precision Instruments, Inc. FFT Class I 1985-07-25
K851955 SAVARY-GILLIARD DILATOR Wilson-Cook Medical, Inc. KNQ Class II 1985-07-25
K844810 NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG C.R. Bard, Inc. KNX Class II 1985-07-24
K852100 THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI Henley Board, Inc. FPD Class II 1985-07-24
K851857 UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER Sheridan Catheter Corp. KOD Class II 1985-07-15
K852726 ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 The Huxley Instrument Corp. KOA Class I 1985-07-09
K852725 BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420 The Huxley Instrument Corp. KOA Class I 1985-07-09
K850020 PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 Pentax Precision Instrument Corp. FDS Class II 1985-07-09
K851672 NYHUS/NELSON TUBE Bissell Medical Products, Inc. KNT Class II 1985-07-09
K851647 OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO Meadox Surgimed, Inc. FGE Class II 1985-07-03
K851684 UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER Urotec Systems Corp. KOD Class II 1985-07-02
K851870 MENTOR UNIVERSAL URETERAL STENT SET Mentor Corp. FAD Class II 1985-07-02
K851681 SAFESTRETCH INCONTINENCE SYSTEM Dbt Medical , Ltd. KNX Class II 1985-06-28
K851679 OSTOMY BAGS COLOSTOMY Dbt Medical , Ltd. EXB Class I 1985-06-27
K851678 OSTOMY BAGS URETHEROSTOMY Dbt Medical , Ltd. EXB Class I 1985-06-27
K851680 OSTOMY BAGS ILEOSTOMY Dbt Medical , Ltd. EXB Class I 1985-06-27
K851266 QRI-FLOW URINE FLOW MEASURING DEVICE Bio-Flow, Inc. KNX Class II 1985-06-27
K851682 SAFESEAL REUSABLE URINAL SYSTEM Dbt Medical , Ltd. EXJ Class I 1985-06-24
K851652 PAPILLOTOME Microvasive KNS Class II 1985-06-24
K851840 STOMAHESIVE SKIN BARRIER STERILE Convatec, A Division of E.R. Squibb & Sons EXB Class I 1985-06-24
K851836 MANAN MENGHINI NEEDLE Manan Manufacturing Co., Inc. KNW Class II 1985-06-21
K851839 MANAN MADAYAG PTC NEEDLE Manan Manufacturing Co., Inc. KNW Class II 1985-06-21
K851838 MANAN CHIBA PTC NEEDLE Manan Manufacturing Co., Inc. KNW Class II 1985-06-21
K850664 ENDO-TUBE Biosearch Medical Products, Inc. KNT Class II 1985-06-21
K851780 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS Artiberia FHQ Class I 1985-06-20
K851779 25-100,25-220 VARIOUS NEEDLE HOLDERS Artiberia FHQ Class I 1985-06-20

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