meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
43
Latest Decision
1987-08-25

Clearances · page 92 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K871978 CODMAN FLEXIBLE ENDOSCOPE Codman & Shurtleff, Inc. GCQ Class II 1987-08-25
K872097 INFANT FEEDING TUBE Tri-State Hospital Supply Corp. KNT Class II 1987-08-25
K872096 INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT Tri-State Hospital Supply Corp. KNT Class II 1987-08-25
K873208 MANAN TURNER STYLE NEEDLE Manan Manufacturing Co., Inc. KNW Class II 1987-08-25
K871999 MMG URO-SELF CATHETER Medical Marketing Group GBM Class II 1987-08-25
K871467 BIOPSY NEEDLE GUIDE KIT, STERILE Amedic USA FCG Class II 1987-08-21
K871738 OSTO-PURE Clearchem Corp. EXB Class I 1987-08-12
K872929 PH MONITORING SYSTEM Sensatronix Medical Systems, Inc. FFT Class I 1987-08-10
K871528 ENTRIMIT GRAVITY FEEDING SET Biosearch Medical Products, Inc. KNT Class II 1987-08-10
K871429 ANTIMICROBIAL FOLEY CATHETER American Pharmaseal Div. Ahsc KOD Class II 1987-08-10
K871787 ENURESIS ALARM Dilorenzo Engineering Co. KPN Class II 1987-08-10
K871691 MODIFIED MULTI-LUMEN NASOGASTRIC TUBE Bissell Medical Products, Inc. KNT Class II 1987-08-10
K871789 INTECARE PEDIATRIC URINE COLLECTOR Mercury Enterprises, Inc. FFH Class II 1987-08-10
K871710 BIOPSY FORCEPS Frantz Medical Development, Ltd. FCL Class I 1987-08-10
K872060 WASHING/INJECTION NEEDLE Endovations FBK Class II 1987-07-21
K871554 MOSS(R) GASTROSTOMY TUBE CAT #5-17719 Mfg. and Research, Inc. KNT Class II 1987-07-21
K871155 DELFLEX RIGID DRAIN CONTAINER Delmed, Inc. KDJ Class II 1987-07-16
K872022 UROVIEW Oec-Diasonics, Inc. KQS Class I 1987-07-16
K871817 VAS-CATH PERITONEAL DIALYSIS CATHETER Vas-Cath of Canada , Ltd. FJS Class II 1987-07-16
K871583 MODIFIED LABELING FOR AMUKIN-50% Amuchina Intl., Inc. KDJ Class II 1987-07-09
K870889 ACID FUCHSIN SOLUTIONS D.R.G. Scientific Industries FKQ Class II 1987-07-08
K871628 PALEX (R) OSTOMY Industrias Palex C/O Dma Med-Chem Corp. EXB Class I 1987-07-08
K870623 ENTERAL ADMINISTRATION SET Plasco, Inc. FPD Class II 1987-06-26
K864592 JUDD URETHAL CATHETER CONTAINER Phil Judd, Inc. KOD Class II 1987-06-24
K871809 FLEXIBLE BIOPSY FORCEP Surgi-Aid Endoscopics, Inc. OCZ Class II 1987-06-18
K870534 DOTOLO COLON HYDROTHERAPY INSTRUMENT Dotolo Research Corp. C/O Keller and Heckman KPL Class II 1987-06-18
K871749 ADULT PERM-CATH 40CM. Quinton, Inc. LFJ Class II 1987-06-17
K871779 HELICAL STONE BASKET (DISPOSABLE) Van-Tec, Inc. FFL Class II 1987-06-17
K871942 PERM-CATH CATHETER KIT Quinton, Inc. LFJ Class II 1987-06-17
K871708 NEO-I TEMPERATURE & CONDUCTIVITY METER Automata, Inc. FIZ Class II 1987-06-17
K871777 VAN-TEC REUSABLE HELICAL STONE BASKET Van-Tec, Inc. FFL Class II 1987-06-17
K871488 VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH Vas-Cath of Canada , Ltd. LFJ Class II 1987-06-12
K871471 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 Travenol Laboratories, S.A. FJI Class II 1987-06-12
K871487 VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH Vas-Cath of Canada , Ltd. LFJ Class II 1987-06-12
K871643 CONVEEN(R) LEG-BAG (600 ML) Coloplast A/S KNX Class II 1987-06-10
K871667 URETERAL STENT Penn Medical Devices, Inc. FAD Class II 1987-06-10
K871610 CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) Coloplast A/S KNX Class II 1987-06-10
K871282 SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE Synectics-Dantec FFT Class I 1987-06-10
K861730 ACTRIL FOR KIDNEY MACHINE DISINFECTANT Renal Systems, Inc. FKQ Class II 1987-06-09
K871019 ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET Entech, Inc. KNT Class II 1987-06-09
K870855 UROSCAN Endotherapeutics FAP Class II 1987-06-09
K871390 BARD BIOPTY BIOPSY SYSTEM C.R. Bard, Inc. KNW Class II 1987-06-05
K871003 ENTROSET-SW White River (Tm) KNT Class II 1987-06-04
K870897 KODNER ANAL PERIONEAL RETRACTOR Sur-Med Instruments, Inc. FFO Class I 1987-06-04
K870979 HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS Inventory Supply Corp. KPO Class II 1987-06-03
K870626 FREEDOM SET II WITH TRIFLEX VALVE Delmed, Inc. KDJ Class II 1987-06-03
K871387 SECOND NATURE(TM) Advanced Clinical Products, Inc. KNX Class II 1987-05-29
K871236 HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H National Medical Care, Medical Products Div., Inc. FJI Class II 1987-05-29
K871630 KITS AND TRAYS FOR DIALYSIS USE Dove Medical Supplies FKG Class I 1987-05-26
K871791 BLOXOM IRRIGATOR I.B. Bloxom C/O Hogan & Hartson EXD Class II 1987-05-20
K871730 MODIFIED USE OF PULL-APART INTRODUCER SET Quinton, Inc. FKO Class II 1987-05-18
K861291 GASTROTOPO Houston Biomedical, Inc. FGE Class II 1987-05-15
K871108 GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER Gambro, Inc. KDI Class II 1987-05-15
K870508 GASTROINTESTINAL TUBE Penn Medical Devices, Inc. KNT Class II 1987-05-11
K870328 SINGLE LUMEN ACUTE CATHETER Quinton, Inc. LFJ Class II 1987-05-11
K870725 FRESENIUS HEMOFLOW F6 AND F8 Seratronics, Inc. FJI Class II 1987-05-01
K871154 DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE Delmed, Inc. KDJ Class II 1987-04-30
K871218 MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT Hospal Medical Corp. FKP Class II 1987-04-30
K871291 AM CATH ESWL STENT Inter-Med Corp. FAD Class II 1987-04-30
K871360 10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE Quinton, Inc. MPB Class II 1987-04-29
K870680 OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) Medline Industries, Inc. FET Class II 1987-04-17
K870577 E-Z LOOP John F. Greer Co., Inc. EXB Class I 1987-04-17
K864683 NEONATAL FEEDING KIT Salt Creek Medical Technologies KNT Class II 1987-04-17
K870165 FOLEY CATHETER Acorn Medical Products KOD Class II 1987-04-17
K870705 THERMAL COAGULATOR Microvasive KNS Class II 1987-04-17
K870471 MODIFIED HR-3000 REUSE ADAPTOR Colorado Medical, Inc. LIF Class II 1987-04-10
K870531 EZ TAC FILTER John F. Greer Co., Inc. EXB Class I 1987-04-10
K870689 HR-3000 REUSE ADAPTOR Colorado Medical, Inc. LIF Class II 1987-04-10
K864833 POS-T-VAC Ekc, Inc. LKY Class II 1987-04-10
K871297 KADIR HI-TORQUE GUIDE WIRE Argon Medical Corp. KOD Class II 1987-04-10
K871049 CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN. Abbott Laboratories KDJ Class II 1987-04-10
K870606 TONOMITOR(TM) Tonometrics Holdings SA C/O Mackeen Consultants FFT Class I 1987-04-10
K871050 CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM. Abbott Laboratories KDJ Class II 1987-04-10
K870169 CAPILLARY FLOW DIALYZERS Travenol Laboratories, S.A. FJI Class II 1987-04-06
K870019 THE LAHR BALLOON Plasco, Inc. FCE Class I 1987-04-01
K870977 PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE American Pharmaseal Div. Ahsc KOD Class II 1987-04-01
K870355 (URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE Cook Urological, Inc. OCZ Class II 1987-04-01
K870785 SOFT TISSUE BIOPSY NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic KNW Class II 1987-04-01
K870504 NORTA (TM) UROBAG Beiersdorf, Inc. KNX Class II 1987-04-01
K870724 FRESENIUS HEMOFLOW F60 AND F80 Seratronics, Inc. KDI Class II 1987-04-01
K870136 PERSONAL PUNCH Arnold Technologies EXB Class I 1987-04-01
K870796 MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY Plasco, Inc. FCE Class I 1987-04-01
K870679 VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE Van-Tec, Inc. FBO Class II 1987-03-30
K870557 VAN-TEC PUMPING SYSTEM Van-Tec, Inc. KOD Class II 1987-03-30
K870696 VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH Van-Tec, Inc. FFL Class II 1987-03-30
K864831 COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS Cobe Laboratories, Inc. FJI Class II 1987-03-27
K863044 CAPILLARY FLOW HOLLOW FIBER DIALYZERS National Medical Care, Medical Products Div., Inc. FJI Class II 1987-03-27
K865078 POWDERED BICARBONATE CONCENTRATE Bicarbolyte Corp. KPO Class II 1987-03-27
K865087 VAN-TEC DOUBLE SHEATH GRASPING FORCEPS Van-Tec, Inc. OCZ Class II 1987-03-25
K871042 URINE METER, 250CC Salt Creek Medical Technologies KNX Class II 1987-03-25
K870615 VAN-TEC POSITIVE OPEN SEGURA BASKET Van-Tec, Inc. FFL Class II 1987-03-25
K865085 KAMINSKY COMBINATION STENT & INJECTION CATHETER Van-Tec, Inc. FAD Class II 1987-03-25
K870735 PROSTATIC ASPIRATION BIOPSY SET Van-Tec, Inc. KNW Class II 1987-03-25
K870811 MODEL 102 PH METER Mesa Medical, Inc. LRI Class II 1987-03-24
K870376 JIMMY JOHN III, COLONIC IRRIGATION SYSTEM Colon Therapeutics KPL Class II 1987-03-17
K863298 DIAMOND MEDICAL, INC., MODEL DM 700 Diamond Medical, Inc. FFT Class I 1987-03-17
K864265 HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI Dial Medical of Florida, Inc. KPO Class II 1987-03-17
K870127 MODIFIED JIMMY JOHN III Colon Therapeutics KPL Class II 1987-03-17
K870145 EXTERNAL Y VALVE 5C4198 Travenol Laboratories, S.A. KDJ Class II 1987-03-10
K870556 VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET Van-Tec, Inc. KOB Class II 1987-03-10

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