meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
52
Latest Decision
1987-03-10

Clearances · page 93 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K864942 BICARBONATE MIXING SYSTEM Morris Tool , Ltd. KPO Class II 1987-03-10
K864874 SEGURA DRETLER BASKET Van-Tec, Inc. FFL Class II 1987-03-10
K865086 WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE Van-Tec, Inc. FBK Class II 1987-03-10
K870694 VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER Van-Tec, Inc. KOD Class II 1987-03-10
K870695 VAN-TEC URETHRAL DILATATION SYSTEM Van-Tec, Inc. KOE Class II 1987-03-10
K870555 VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET Van-Tec, Inc. KOB Class II 1987-03-10
K870734 TEFLON BIOPSY CATHETER W/TIP ANGLE Van-Tec, Inc. KNW Class II 1987-03-10
K870697 VAN-TEC ONE STEP URETERAL DILATATION CATHETER Van-Tec, Inc. EZN Class II 1987-03-10
K862928 AMUKIN-50% FOR CAPD Y-SET Amuchina Intl., Inc. FKX Class II 1987-03-09
K864140 KIDNEY PERFUSION MACHINE Advanced Equipment Development, Inc. KDN Class II 1987-03-05
K870394 HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS Clinical Connections, Inc. FIB Class II 1987-03-03
K864587 FRESENIUS ULTRAFLUX AV400, AV600 Seratronics, Inc. KDI Class II 1987-03-03
K870472 ACUTE PERITONEAL DIALYSIS KIT Quinton, Inc. FKO Class II 1987-02-25
K863609 SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 International Medical Products, Inc. FKP Class II 1987-02-25
K870270 MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. Ash Medical Systems, Inc. FKT Class II 1987-02-25
K864770 SUCTION TUBE New England Surgical Instrument Corp. FFA Class II 1987-02-24
K870240 COMPRESS AND SKULLCAP, HEAD DRESSING Fraass Survival Systems, Inc. EXR Class II 1987-02-20
K865096 NEW SECOND FRENCH SIZE MAHURKAR CATHETER Quinton, Inc. LFK Class II 1987-02-18
K863218 CYTOSTATIC FILTRATION SET Meadox Surgimed, Inc. LFK Class II 1987-02-12
K861821 KEYMED FIBERSCOPE AUTO DISINFECTOR Keymed, Inc. NVE Class II 1987-02-12
K864835 TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* Eisai U.S.A., Inc. FCD Class I 1987-02-11
K864364 WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET Technical Associates of New England KNT Class II 1987-02-11
K864960 TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. Cooper Lasersonics, Inc. GCQ Class II 1987-02-10
K864904 3F ELECTRODE Northgate Research, Inc. FFK Class II 1987-02-10
K864448 THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM) Biosonics, Inc. KPN Class II 1987-02-06
K863819 CHEMO-CATH INTRAPERITONEAL CATHETER Hdc Corp. FJS Class II 1987-02-04
K862402 OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES Medivators, Inc. NVE Class II 1987-02-03
K863227 COOK-VPI CONTINENCE CUFF Cook Urological, Inc. FHA Class I 1987-02-03
K864225 ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT Angiomed U.S., Inc. FAD Class II 1987-01-30
K864784 SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS Cd Medical, Inc. FJK Class II 1987-01-20
K861267 UROCUT BIOPSY NEEDLE Meadox Surgimed, Inc. KNW Class II 1987-01-20
K864385 LUXTEC LIGHT SOURCES Luxtec Corp. FCW Class II 1987-01-13
K864635 FOUR TANK DISSOLUTION MODULE National Medical Care, Medical Products Div., Inc. FKQ Class II 1987-01-13
K864218 PROCON Healthcare Management Systems KNT Class II 1987-01-12
K864669 AM CATH ESWL STENT Inter-Med Corp. FAD Class II 1987-01-05
K864736 AKRO-SIL PLUS Akron Catheter, Inc. KOD Class II 1986-12-24
K864846 RADIOGRAPHIC - LEG SECTION American Sterilizer Co. KQS Class I 1986-12-24
K864801 THE KEYMED HI-LIGHT 250 LIGHT SOURCE Keymed, Inc. GCT Class II 1986-12-24
K863492 METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI. Surgitek FAD Class II 1986-12-18
K863961 HOSPAL BIOSPAL 1800S Hospal Medical Corp. KDI Class II 1986-12-17
K861309 JEJUNAL FEEDING TUBE Microvasive KNT Class II 1986-12-16
K864629 MODIFIED DUAL LUMEN NEEDLE Quinton, Inc. LBW Class II 1986-12-16
K861323 REPLACEMENT GASTROSTOMY TUBE Microvasive KNT Class II 1986-12-16
K864179 BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR Ash Medical Systems, Inc. FKT Class II 1986-12-11
K862838 CYTOTECH HSV IGG ENZYME IMMUNOASSAY Cytotech, Inc. GCO Class II 1986-12-09
K864413 MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE Cooper Lasersonics, Inc. KNS Class II 1986-12-09
K864189 ULTRA-GEL - #4083 John F. Greer Co., Inc. EXB Class I 1986-12-04
K864188 E-Z HOLD WITH ADHESIVE BASE.-#4065 John F. Greer Co., Inc. KNX Class II 1986-12-04
K864182 ENTERAL ADMINISTRATION ADAPTERS Biosearch Medical Products, Inc. KNT Class II 1986-12-04
K863642 CANDELA MODEL MDL-1 LASER LITHOTRIPTOR Candela Corp. FFK Class II 1986-12-03
K863312 SANDHILL AMS Sandhill FAP Class II 1986-12-03
K864329 MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT Dlp, Inc. KNW Class II 1986-12-03
K860858 OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE Olympus Corp. LYK Class II 1986-11-20
K862878 FREE & ACTIVE(TM) ABSORBENT PADS Convatec, A Division of E.R. Squibb & Sons EYQ Class I 1986-11-19
K862877 MALE URINARY STRESS PAD* Convatec, A Division of E.R. Squibb & Sons EYQ Class I 1986-11-19
K861699 CATHETER VALVES KV 100 & KV 100EH Max Staubli , Ltd. KOD Class II 1986-11-19
K862727 ZINETICS GASTROMETER (TM) Zinetics Medical Technology Corp. FFT Class I 1986-11-19
K862098 PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH Hall/Mccollum Laboratories, Inc. KOD Class II 1986-11-12
K862683 BIOSOICS SPHINCTER TRAINING SYSTEM Biosonics, Inc. KPN Class II 1986-11-12
K864094 GAMBRO FLUID CONTROL MONITOR FCM 10-1 Gambro, Inc. FKP Class II 1986-11-07
K863082 COOK-VPI INTERMITTENT CATHETER Cook Urological, Inc. KOD Class II 1986-11-07
K864169 FRESENIUS HEMOFLOW F50 & F70 Seratronics, Inc. KDI Class II 1986-11-06
K863823 AMICON DIAFILTER HEMOFILTER Amicon, Inc. KDI Class II 1986-11-06
K864083 GAMBRO BICARBONATE MONITOR BCM 10-2 Gambro, Inc. FKP Class II 1986-11-06
K863571 BILIARY BALLOON CATHETER Uresil Corp. FGE Class II 1986-11-04
K863354 BIO-GUARD AB COATED CATHETER Cook Urological, Inc. KOD Class II 1986-11-04
K862855 CRAIG NASO-GASTRIC TUBE HOLDER Henley Intl. KNT Class II 1986-11-04
K863273 MARTIN MEDICAL PRO-SCOPE ANOSCOPE Martin Medical KOA Class I 1986-11-04
K862059 SHEATH, ENDOSCOPE Endovations FGE Class II 1986-11-04
K863958 TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY Cathaid, Inc. KOD Class II 1986-11-04
K862949 HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER Oscor Medical Corp. LQR Class II 1986-10-31
K863517 FOLEY CATHETERS Instrumentation Industries, Inc. KOD Class II 1986-10-31
K863281 CARE + PLUS IRREGATION TRAY Welmed Systems, Inc. KOD Class II 1986-10-31
K863282 CARE + PLUS CATHETER CARE TRAY Welmed Systems, Inc. KOD Class II 1986-10-31
K862757 STARCHILD SLEEPDRY Starchild, Inc. KPN Class II 1986-10-29
K863720 HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES Water Pure, Inc. FIP Class II 1986-10-29
K863437 BARD BALLOON DILATATION SYSTEM C.R. Bard, Inc. FGE Class II 1986-10-29
K863165 MODEL 4-SC FOUR WAY STOPCOCK Life-Tech Intl., Inc. FAP Class II 1986-10-28
K863824 SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. D.R.G. Scientific Industries FKH Class II 1986-10-24
K863957 TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU Cathaid, Inc. FGE Class II 1986-10-24
K862872 FLEXIBLE VISUALIZATION CATHETER American Edwards Laboratories FEI Class I 1986-10-24
K863168 MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD Life-Tech Intl., Inc. FAP Class II 1986-10-24
K863167 MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR Life-Tech Intl., Inc. FAP Class II 1986-10-24
K864040 BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS C.R. Bard, Inc. FAE Class II 1986-10-24
K863386 VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS Angiomed U.S., Inc. KOB Class II 1986-10-24
K863081 4-WIRE (CARSON) STONE EXTRACTOR Cook Urological, Inc. FFL Class II 1986-10-24
K862729 PENN 3-RING HANDLE Penn Medical Devices, Inc. FFL Class II 1986-10-24
K863120 (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET Cook Urological, Inc. KOB Class II 1986-10-24
K863739 BESCURE U-T, Inc. KNX Class II 1986-10-24
K862929 SYNECTICS MOTILITY SYSTEM Synectics-Dantec FFT Class I 1986-10-20
K861904 HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE Cooper Lasersonics, Inc. KNS Class II 1986-10-16
K863830 CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM Coloplast A/S EZQ Class I 1986-10-16
K863539 HYDRO-CLENZ UNIT Atlantic Health Group KPL Class II 1986-10-16
K862631 BARD IRYFIX(TM) STOMA CAP C.R. Bard, Inc. EXB Class I 1986-10-16
K863631 SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS American Healthcare Corp. KPO Class II 1986-10-16
K862562 PUNCH BIOPSY KIT Clinipad Corp. KNW Class II 1986-10-07
K863302 MODIFIED FOLEY CATHETER Sheridan Catheter Corp. KOD Class II 1986-10-03
K862090 MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAG Kendall Mcgaw Laboratories, Inc. FPD Class II 1986-10-03
K863671 PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5 Samco Industries, Inc. KNX Class II 1986-10-03
K863330 DISPOSABLE PNEUMOPERITONEUM NEEDLE United States Surgical, A Division of Tyco Healthc FHO Class II 1986-10-02

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