meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
48
Latest Decision
1982-04-16

Clearances · page 105 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K820965 DISSCAP 140 Hospal Medical Corp. FKQ Class II 1982-04-16
K820961 INCONTINENCE PAD OR ADULT DIAPER Dafoe & Dafoe, Inc. EYQ Class I 1982-04-16
K820859 COAXIAL DUAL FLOW CATHETER Terumo Medical Corp. LBW Class II 1982-04-16
K820973 ENDOSCOPIC INJECTION NEEDLE Mill-Rose Laboratory FBK Class II 1982-04-16
K813585 WATERS ILEOSTOMY VALVE Waters Instruments, Inc. KNT Class II 1982-04-09
K820431 E.R.C.P. CANNULAS American Endoscopy, Inc. ODD Class II 1982-04-09
K820430 DIATHERMIC SNARES American Endoscopy, Inc. KNS Class II 1982-04-08
K820429 SPIRAL STONE AND RETRIEVAL BASKETS American Endoscopy, Inc. OCZ Class II 1982-04-08
K820624 SYN-OPTICS #5200 Syn-Optics FET Class II 1982-04-01
K820790 FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 American Optical Corp. FAM Class II 1982-04-01
K820565 MALE EXTERNAL CATHETER Urocare Products, Inc. KNX Class II 1982-04-01
K820694 COBE PPD 1.3L, #18-520-009 Cobe Laboratories, Inc. FJG Class II 1982-03-31
K813591 HEMOFILTERS Amicon, Inc. KDI Class II 1982-03-31
K820239 RETRIEVAL FORCEPS American Endoscopy, Inc. KOD Class II 1982-03-26
K820240 PAPILLOTOMES American Endoscopy, Inc. KNS Class II 1982-03-26
K820637 CATH-HOLD Womco Products KOD Class II 1982-03-25
K820243 CONTINUOUS BLOOD PROCESSOR CBP-6000 & Bentley Laboratories, Inc. KDI Class II 1982-03-25
K820221 HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE Renal Systems, Inc. LIF Class II 1982-03-23
K820173 COBE SINGLE-NEEDLE CONTROLLER #18-756 Cobe Laboratories, Inc. FIF Class II 1982-03-23
K820566 PATIENT ISOLATOR #S-10/D-10 Microelectrodes, Inc. FFT Class I 1982-03-23
K813107 COMPUDIAL/KP-1 Computer Dialysis Systems, Inc. LIF Class II 1982-03-23
K820420 AM. PH. STERILE FEEDING TUBE American Pharmaseal Div. Ahsc KNT Class II 1982-03-23
K813574 SORB II Organon Teknika Corp. FKT Class II 1982-03-23
K820419 AM. PH. STERILE SINGLE-USE URETHRAL CATH American Pharmaseal Div. Ahsc KOD Class II 1982-03-23
K820144 DISA WATER CYSTOMETER Disa Electronics FAP Class II 1982-03-23
K820441 ARGYLE PVC FEEDING TUBE Sherwood Medical Co. KNT Class II 1982-03-10
K820237 COBE ACUFLEX FSN, #15-208 Cobe Laboratories, Inc. LFK Class II 1982-03-10
K820442 ARGYLE INDWELL FEEDING TUBE Sherwood Medical Co. KNT Class II 1982-03-10
K820493 DEEP CONVEX FACE PLATE Smith'S Ostomy Products, Inc. EXB Class I 1982-03-10
K820238 COBE ACUFLEX SSN, #15-220 Cobe Laboratories, Inc. LFJ Class II 1982-03-10
K812802 CAPD U.V. GERMICIDAL CONNECTION SYSTEM Travenol Laboratories, S.A. KDJ Class II 1982-03-02
K820405 GROUND AID CAPHESIVE Promedicon, Inc. KNS Class II 1982-03-02
K820304 GAMBRO GF-80-M, GF-80-H HEMODIALYZER Gambro, Inc. FJI Class II 1982-03-02
K812995 VANCE-JACOBELLIS MICROHEMATURIA CATHETER Vance Products, Inc. KOD Class II 1982-03-01
K820313 VPI-FAIR URETHRAL STENT Vance Products, Inc. KOD Class II 1982-03-01
K813462 MADAYAG TYPE NEEDLE Ocean Medical Products, Ltd. KNW Class II 1982-03-01
K820293 BONE BIOPSY SET The Anspach Effort, Inc. KNW Class II 1982-03-01
K813641 VITAL METRICS URINE MONITORING SYSTEM Vital Metrics, Inc. FFG Class II 1982-03-01
K820015 URETHAL CUTTER CLAMP Lone Star Medical Products, Inc. KOA Class I 1982-02-22
K820179 ERIKA CAPD PREP KIT #30-9501-5 Erika, Inc. FKX Class II 1982-02-19
K820167 LAMINATED KARAYA GUM WASHERS Atlantic Surgical EXB Class I 1982-02-18
K820196 ELECTROSURGICAL DISP. DISPERSIVE PAD Promedicon, Inc. KNS Class II 1982-02-12
K813621 CURITY BEDSIDE DRAINAGE BAG The Kendal Co. KNX Class II 1982-02-12
K813325 KEY MED FOREIGN BODY REMOVAL TUBE Keymed, Inc. FED Class II 1982-02-10
K820234 HOLLISTER FEMALE URINARY COLLECT SYS Hollister, Inc. KNX Class II 1982-02-10
K820176 VYGON ENTERNAL NUTRITION TUBES Exco, Inc. KNT Class II 1982-02-05
K820169 MALE LUER CONNECTOR & HINGED CAP Extracorporeal Medical Specialities, Inc. FJK Class II 1982-02-05
K820152 KEY MED LEEDS ENDOSCOPE DISINFECTOR Keymed, Inc. FEB Class II 1982-01-29
K813586 DIALYSIS CONCENTRATE Diversified Medical Services KPO Class II 1982-01-29
K820150 K-AID Sytek Laboratories KPO Class II 1982-01-29
K820136 URINARY DRAINAGE BAG Megaplast, Inc. KNX Class II 1982-01-29
K820081 ESKA JONAS SILICONE-SILVER PENILE PROST Dacomed Corp. FAE Class II 1982-01-25
K813537 URIFIX Isramed, Inc. KNX Class II 1982-01-12
K813526 FECAL SANITARY TUBE Leon'S Fecal Sanitary Tub Mfg. KNT Class II 1982-01-12
K813434 ELECTROSURGICAL DISP. DISPERSIVE PAD Promedicon, Inc. KNS Class II 1982-01-12
K813132 THE CHICAGO GULLET Universal Prosthetics, Inc. KNT Class II 1982-01-07
K813479 ARGYLE PEDIATRIC URINE COLLECTOR Sherwood Medical Co. KNX Class II 1982-01-07
K813504 ACESSORY TO MODIFIED FREEDING JEJUNOSTO Midwest Metabolic Support Group KOA Class I 1982-01-07
K812615 TM-CAPD Tri-Med, Inc. KPP Class II 1982-01-05
K813494 WATERS ILEAL RESERVOIR CATHETER Waters Instruments, Inc. KPH Class I 1981-12-31
K813388 HEMODIALYSATE Edlaw Pharmaceuticals, Inc. KPO Class II 1981-12-31
K813428 SHUNT ADAPTER Quinton, Inc. FKN Class II 1981-12-31
K813084 CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET Burron Medical Products, Inc. KOB Class II 1981-12-31
K813082 UREOFIX 500 URINE MEASURING SYSTEM Burron Medical Products, Inc. FFG Class II 1981-12-31
K813487 CATHETER BUBBLE STAND Accurate Surgical Instruments Co. FKX Class II 1981-12-31
K813488 CATHETER REGULAR Accurate Surgical Instruments Co. FJS Class II 1981-12-31
K813336 LAZARUS-NELSON PERITONEAL LAVAGE TRAY American Pharmaseal Div. Ahsc FKO Class II 1981-12-18
K813278 VPI URETERAL DILATATION BALLON CATHETER Vance Products, Inc. EZN Class II 1981-12-18
K813332 BRISTOL BALLON INTRODUCER, MANDRIL SET Inmed Corp. NWU Class II 1981-12-14
K813270 FECAL INCONTINENCE COLLATOR Hollister, Inc. EXB Class I 1981-12-14
K812869 D-3260 SORBENT CARTRIDGE Organon Teknika Corp. FKT Class II 1981-12-08
K812811 MICROCOIL 80 DIALYZER Erika, Inc. FHS Class II 1981-12-03
K813269 TWO PIECE OSTOMY SYSTEM Hollister, Inc. EXB Class I 1981-12-03
K813169 CELESTIN PULSION ESOPHOGEAL PROSTHESIS Inmed Corp. KNT Class II 1981-12-03
K813237 HEMASITE VASCULAR ACCESS SHUNT HM-1000 Renal Systems, Inc. FIQ Class II 1981-11-30
K813085 HEPAFIX BIOPSY NEEDLE SET Burron Medical Products, Inc. KNW Class II 1981-11-20
K812887 ROBINSON CATHETERS NON-STERILE Abco Dealers, Inc. KOD Class II 1981-11-17
K813026 GUIDE WIRE Inmed Corp. OCY Class II 1981-11-17
K812810 PENTAX FLEXIBLE DRIODENOFIBERSCOPE Pentax Precision Instrument Corp. FAK Class II 1981-11-17
K813080 WOUND DRAINAGE MANAGEMENT SYSTEMS Howmedica Corp. EXB Class I 1981-11-17
K812890 HEMASITE GRAFTLESS VASCULAR ACESS Renal Systems, Inc. FIQ Class II 1981-11-16
K811972 EXTRASENSR ULTRAFILTRATION MONITOR Extracorporeal Medical Specialities, Inc. FKP Class II 1981-11-16
K813069 PERITONEAL DIALYSIS CYCLER SET American Medical Products, Inc. KDJ Class II 1981-11-16
K811924 PRE-FILLED SYRINGE & CYSTOFLO URINARY BG Travenol Laboratories, S.A. KOD Class II 1981-11-10
K812230 MODEL RS 8300 Renal Systems, Inc. LIF Class II 1981-11-06
K812213 AUTOMATED ELECTROCAUTERY SYSTEM University of Washington KNS Class II 1981-11-05
K812907 FEMEX Promac KNX Class II 1981-11-02
K812965 MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE American Optical Corp. FAM Class II 1981-11-02
K812718 CUFF MATERIAL ON PEDIATRIC SIZE CATH. Quinton, Inc. FJS Class II 1981-10-19
K812771 PERITONEAL DIALYSIS DRAINAGE Dravon Medical, Inc. KDJ Class II 1981-10-19
K812201 PHOTOGRAPHIC EQUIPMENT Reznik Instruments FEM Class I 1981-10-19
K812575 MODEL H12-10 Hospal Medical Corp. KDI Class II 1981-10-19
K812717 NON-STERILE SHADOW-STRIPE CATHETER Quinton, Inc. FKO Class II 1981-10-19
K812772 PERITONEAL DIALYSIS CYCLER SET (8UNIT) Dravon Medical, Inc. KDJ Class II 1981-10-19
K812542 POLAROID INSTANT ENDOCAMERA Polaroid Corp. FEM Class I 1981-10-19
K812281 TOUCHLESS HOME-CATH Diamed Division Ill. Tool Works, Inc. KOD Class II 1981-10-13
K812607 TENCKHOFF PERITONEAL CATHETERS Quinton, Inc. FJS Class II 1981-10-02
K812330 DIALYSATE CONCENTRATE Central Biological Co. FKQ Class II 1981-09-29
K812648 EHTOX GASTRIC LAVAGE KIT #2050 & #2070 Ethox Corp. KNT Class II 1981-09-29
K812498 CLIRANS TE12 HOLLOW FIBER DIALYZER Terumo Medical Corp. KOC Class II 1981-09-29

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