meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
53
Latest Decision
1996-07-24

Clearances · page 62 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960176 DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER C.R. Bard, Inc. FEG Class II 1996-07-24
K961371 SUBCUTANEOUS URINARY DIVERSON STENT SET Cook Urological, Inc. FAD Class II 1996-07-24
K954713 DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) Ideas For Medicine, Inc. FGE Class II 1996-07-24
K953875 CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) In-Line Diagnostics Corp. MQS Class II 1996-07-23
K962416 DRYTIME FOR BLADDER CONTROL SILENT Bio-Systems Research KPN Class II 1996-07-22
K961762 REUSABLE ENDOSCOPIC ACCESSORY HANDLE United States Endoscopy Group, Inc. KNS Class II 1996-07-22
K961182 3D SCOPE Oktas GCJ Class II 1996-07-19
K962604 PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING Convatec, A Division of E.R. Squibb & Sons FAQ Class I 1996-07-18
K961611 OLYMPUS BASKET GRASPERS (UROLOGY) Olympus America, Inc. OCZ Class II 1996-07-18
K962365 XENON LIGHTSOURCE Dsp Worldwide GCT Class II 1996-07-18
K961846 NEEDLE CATHETER Boston Scientific Corp FBK Class II 1996-07-15
K962413 COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER Sierra Laboratories, Inc. EXJ Class I 1996-07-15
K962384 COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER Sierra Laboratories, Inc. EXJ Class I 1996-07-15
K961036 MBI FIBEROPTIC ENDO-ILLUMINATOR M.B. Industries, Inc. MPA Class II 1996-07-15
K961940 INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP Innerdyne, Inc. GCJ Class II 1996-07-10
K961568 ED-344OT Pentax Precision Instrument Corp. FDT Class II 1996-07-09
K961564 EG-2940, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. FDS Class II 1996-07-09
K962024 S-57 VIDEO IMAGING SYSTEM Del Medical Systems Corp. FET Class II 1996-07-09
K962147 DEXTERITY PNEUMO SLEEVE SET Medical Creative Technologies, Inc. GCJ Class II 1996-07-09
K955845 LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS Surgical Image Laboratories, Inc. GCJ Class II 1996-07-05
K962395 SPECIMEN RETRIEVAL BAG Applied Medical Resources GCJ Class II 1996-07-05
K941460 FRESENIUS BLOOD TEMPERATURE MONITOR Fresenius USA, Inc. MQS Class II 1996-07-03
K960496 LIBERTY LITE PFS SYSTEM Utah Medical Products, Inc. KPI Class II 1996-06-27
K960173 INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT Gabriel Medical, Inc. FAT Class II 1996-06-27
K942867 CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 Clearwater Colon Hydrotherapy, Inc. KPL Class II 1996-06-26
K961390 ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER Ethicon Endo-Surgery, Inc. OCW Class II 1996-06-25
K961567 ES-3840, VIDEO SIGMOIDOSCOPE Pentax Precision Instrument Corp. FAM Class II 1996-06-24
K961570 KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) Pentax Precision Instrument Corp. FDF Class II 1996-06-24
K953551 KNOW-RECIRC H&H Control Systems MQS Class II 1996-06-21
K962073 URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY Continental Medical Laboratories, Inc. FCM Class II 1996-06-21
K961563 EC-384OTL, VIDEO COLONSCOPE Pentax Precision Instrument Corp. FDF Class II 1996-06-19
K960637 5MM ENDOSCOPE Origin Medsystems, Inc. GCJ Class II 1996-06-14
K961137 ATI PLASMA PUMP (PP-04) Apheresis Technologies, Inc. FIR Class II 1996-06-14
K955423 PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM Fresenius USA, Inc. FKP Class II 1996-06-13
K961040 BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC Dayspring Medical, Inc. FJI Class II 1996-06-11
K962004 AQ HYDROPHILIC UROLOGICAL CATHETERS Cook Urological, Inc. EYB Class II 1996-06-11
K961070 ESOPHAGEAL MANOMETRY ANALYSIS MODULE Synectics Medical, Inc. KLA Class II 1996-06-11
K961026 BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL Dayspring Medical, Inc. FJI Class II 1996-06-10
K952513 LESE STENTS SETS Cook Urological, Inc. FAD Class II 1996-06-10
K961056 BIOVIEW MODEL S960000 Sandhill Scientific, Inc. KLA Class II 1996-06-06
K955181 U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE United States Endoscopy Group, Inc. KNT Class II 1996-06-05
K955182 NIPRO ARTERIAL VENOUS FISTULA NEEDLE Nissho Corp. FIE Class II 1996-06-04
K954798 7100 SWALLOWING WORKSTATION Kay Elemetrics Corp. KLA Class II 1996-06-04
K945559 MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS Mar Cor Services, Inc. FIP Class II 1996-05-28
K961430 INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP Innerdyne, Inc. GCJ Class II 1996-05-28
K961248 BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS C.R. Bard, Inc. FFL Class II 1996-05-28
K961069 ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM Arthrocare Corp. FAS Class II 1996-05-28
K961446 AQ HYDROPHILIC STENT Cook Urological, Inc. FAD Class II 1996-05-28
K961216 MANAN INTRODUCER SHEALTH/NEEDLE Manan Medical Products, Inc. FGE Class II 1996-05-23
K955248 U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT United States Endoscopy Group, Inc. KNT Class II 1996-05-21
K961224 HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM Davol Inc., Sub. C. R. Bard, Inc. GCJ Class II 1996-05-16
K961492 HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 Davol Inc., Sub. C. R. Bard, Inc. GCJ Class II 1996-05-15
K961349 INJECTION GOLD PROBE Boston Scientific Corp KNS Class II 1996-05-15
K960787 TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS Baxter Healthcare Corp LJH Class II 1996-05-14
K950712 PORTABLE ENDOSCOPY SYSTEM Laser-Optik-Systeme GmbH & Co. KG GCM Class II 1996-05-14
K960677 KANGAROO JEJUNAL FEEDING SYSTEM Sherwood Medical Co. KNT Class II 1996-05-13
K955126 LMI BILIARY CATHETER Lucas Medical, Inc. FGE Class II 1996-05-10
K961262 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc. FGE Class II 1996-05-10
K961442 UNIVERSAL DRAINAGE TRAY Customed, Inc. FCM Class II 1996-05-09
K960632 KANGAROO FEEDING TUBE PLACMENT STYLET Sherwood Medical Co. KNT Class II 1996-05-09
K955728 CORDIS BILIARY STENT Cordis Corp. FGE Class II 1996-05-08
K954215 MINIGUARD Advanced Surgical Intervention, Inc. MNG Class I 1996-05-08
K960872 CYSTOSCOPE 0/15/30/70 DEGREES Pollux Endoscopy, Inc. FAJ Class II 1996-05-07
K960655 AESOP SYSTEM AND ACCESSORIES Computer Motion, Inc. GCJ Class II 1996-05-03
K960519 MARTECH ENDOSCOPIC INJECTION NEEDLE Martech Medical Products, Inc. FBK Class II 1996-05-01
K960757 KARL STORZ URETER RESECTOSCOPE KARL STORZ Endoscopy-America, Inc. FJL Class II 1996-05-01
K961185 DAUM BIOPSYNEEDLE Ferguson Medical FCG Class II 1996-04-30
K952631 BRAUN HEMODIALYSIS BLOOD CIRCUITS B.Braun Medical, Inc. FJK Class II 1996-04-30
K955247 OLYMPUS KD SERIES SPHINCTEROTOME Olympus America, Inc. KNS Class II 1996-04-30
K960415 WILSON-COOK BALLOON INFLATION DEVICE Wilson-Cook Medical, Inc. KNT Class II 1996-04-26
K960562 GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005 Conmedcorp GCJ Class II 1996-04-26
K954710 VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. Northgate Technologies, Inc. FAS Class II 1996-04-24
K944866 VIASPAN (BELZER UW - CSS) The Dupont Merck Pharmaceutical Co. KDL Class II 1996-04-22
K960323 KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE KARL STORZ Endoscopy-America, Inc. FGB Class II 1996-04-22
K960949 PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 Bristol-Myers Squibb KNX Class II 1996-04-19
K931336 DRS 4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. LIF Class II 1996-04-18
K955717 ENDOSCOPE INTRODUCER KIT Mitsubishi Cable America, Inc. FDE Class II 1996-04-18
K954272 INNOVA RECTAL STIMULATON ELECTRODE Empi KPI Class II 1996-04-15
K944673 MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE Regulatory & Marketing Services, Inc. EZL Class II 1996-04-10
K954614 EOS BRAND DISPOSABLE PROCTOSCOPE North Eos Industries, Inc. GCP Class II 1996-04-10
K942247 SMALL BOWEL ANALYSIS SOFTWARE Sandhill Scientific, Inc. FFX Class II 1996-04-09
K960748 MODIFIED HAND INSTRUMENT DEVICES United States Surgical, A Division of Tyco Healthc GCJ Class II 1996-04-05
K944676 MRI'S ALL SILICONE FOLEY CATHETER Mri Manufacturing and Research, Inc. EZL Class II 1996-04-05
K961175 TROGARD TROCAR DIALATING TROCAR SYSTEM Conmedcorp GCJ Class II 1996-04-05
K960065 TEMNO DOUBLE SHOT BIOPSY NEEDLE Bauer Medical, Inc. KNW Class II 1996-04-05
K960064 TEMNO ACHIEVE BIOPSY NEEDLE Bauer Medical, Inc. KNW Class II 1996-04-05
K960866 LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. Lake Region Mfg., Inc. KNY Class II 1996-04-05
K960509 18 GAUGE TRU-CUT BIOPSY NEEDLE Baxter Healthcare Corp KNW Class II 1996-04-04
K953355 GIP/MEID-GLOBE HOT BIOPSY FORCEPS Medi-Globe Corp. KGE Class II 1996-04-04
K954999 LILY MULTICANNULA GUIDE Lily Imaging Solutions Co. KNW Class II 1996-04-04
K955076 SAFE TEE Pearson Strach Medical GCJ Class II 1996-04-02
K960215 CPR URETHRAL CATHETER TRAY Custom Pack Reliability FCM Class II 1996-04-01
K960020 SOLO BAND LIGATOR Surcraft, LLC FHN Class II 1996-04-01
K960214 CPR FOLEY CAHTETER KIT Custom Pack Reliability FCM Class II 1996-04-01
K954451 EVIS 140 SYSTEM Olympus America, Inc. FET Class II 1996-03-29
K960177 P.E.G. PATIENT CARE KIT United States Endoscopy Group, Inc. KNT Class II 1996-03-29
K954879 PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION) United States Endoscopy Group, Inc. KNT Class II 1996-03-29
K955650 OLYMPUS SD SERIES SNARES Olympus America, Inc. FDI Class II 1996-03-29
K960217 CPR URINE BAG Custom Pack Reliability FAQ Class I 1996-03-28
K954132 MANAN MANTA CATHETER FIXATION DISK Manan Medical Products, Inc. KNY Class II 1996-03-26

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