meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
48
Latest Decision
1995-03-23

Clearances · page 67 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K944389 R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 R & D Batteries, Inc. FCO Class I 1995-03-23
K944348 R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 R & D Batteries, Inc. FCO Class I 1995-03-23
K945870 R&D PART NOS. 5490, 5541, 5358, 5497 R & D Batteries, Inc. FCO Class I 1995-03-23
K943593 SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM Ovamed Corp. ODF Class II 1995-03-22
K951082 CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE Stephen Chakoff, Inc. GCJ Class II 1995-03-22
K945889 KARL STORZ PLASTIC SURGERY ACCESSORIES KARL STORZ Endoscopy-America, Inc. GCM Class II 1995-03-22
K945806 SILICATH ALL SILICONE FOLEY CATHETER Unomedical Sdn Bhd EZL Class II 1995-03-21
K950976 KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS KARL STORZ Endoscopy-America, Inc. FBK Class II 1995-03-21
K932055 PERCUPUMP II E-Z-Em, Inc. FIH Class II 1995-03-21
K944571 PULSE GUARD 3FR ELECTRODE Northgate Technologies, Inc. FFK Class II 1995-03-17
K950729 OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) Olympus America, Inc. ODD Class II 1995-03-17
K942941 CONQUEST MALE CONTINENCE SYSTEM Convatec, A Bristol-Myers Squibb Co. EXJ Class I 1995-03-17
K920849 TRIP CIC CATHETER Tonometrics, Inc. FFT Class I 1995-03-17
K951086 NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES American Hydro-Surgical Instruments, Inc. GCJ Class II 1995-03-16
K951060 KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRN KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-03-16
K950433 KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES KARL STORZ Endoscopy-America, Inc. FGA Class II 1995-03-15
K951048 RITE-BITE BIOPSY FORCEPS Mill-Rose Laboratory FCL Class I 1995-03-15
K950924 ASLAN KNOT PUSHER Aslan Medical Technologies, Ltd. FDE Class II 1995-03-14
K944143 MS CLASSIQUE BALLOON CATHETER Meadox Surgimed, Inc. FGE Class II 1995-03-13
K941851 DUAL LUMEN CATHETER (DLC) TRAY Neostar Medical Technologies, Inc. KOC Class II 1995-03-13
K933883 GAMBRO FH 66 D HEMOFILTER Cobe Renal Care, Inc. KDI Class II 1995-03-13
K941350 WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER Wilson-Cook Medical, Inc. FGE Class II 1995-03-09
K945061 NOPROFILE OLBERT CATHETER SYSTEM Meadox Surgimed, Inc. KOD Class II 1995-03-09
K944972 URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY Myo/Kinetic Systems, Inc. EXY Class II 1995-03-08
K945140 URO-FLO Mallinckrodt Group, Inc. LJH Class II 1995-03-08
K945596 ALTRES(R) 140 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-03-08
K945597 ALTRES(R) 170 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-03-08
K945295 LSVP INTERNATIONAL GRASPING FORCEPS Lsvp Intl., Inc. LQR Class II 1995-03-08
K945595 ALTREX(R) 200 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-03-08
K941692 FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER Rochester Medical Corp. EZL Class II 1995-03-06
K944521 RECHARGEABLE BATTERIES R & D Batteries, Inc. FCO Class I 1995-03-06
K950689 UCB Cox Medical Ent., Inc. MNL Class I 1995-03-06
K930503 CLIRANS WET PACK HOLLOW FIBER DIALYZER Terumo Medical Corp. FJI Class II 1995-03-06
K946296 QUADRA-COIL URETERAL STENT Surgitek FAD Class II 1995-03-06
K950745 CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES) Stephen Chakoff, Inc. GCJ Class II 1995-03-06
K950744 CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE) Stephen Chakoff, Inc. GCJ Class II 1995-03-06
K950747 CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) Stephen Chakoff, Inc. GCJ Class II 1995-03-06
K950746 CHAKOFF ENDOSCOPY (SET LAPAROSCOPY) Stephen Chakoff, Inc. GCJ Class II 1995-03-06
K950748 CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) Stephen Chakoff, Inc. GCJ Class II 1995-03-06
K945209 PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS KARL STORZ Endoscopy-America, Inc. GCF Class II 1995-03-06
K950810 RUTNER BIOPSY DEVICE Cook Urological, Inc. FCG Class II 1995-03-06
K950633 CANDELA URETHRAL/BLADDER SOUND Candela Laser Corp. FBX Class I 1995-03-06
K945868 R&D PART NOS. 5262, 5543, 5432, 5469 R & D Batteries, Inc. FCO Class I 1995-03-06
K946360 MODULAR BIOPSY FORCEP Cox Medical Ent., Inc. FCL Class I 1995-03-06
K946089 NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA American Hydro-Surgical Instruments, Inc. GCJ Class II 1995-03-06
K950103 LAPAROSCOPE, HAND INSTRUMENTS Olympus America, Inc. GCJ Class II 1995-03-06
K950076 LAPAROSCOPE Olympus America, Inc. GCJ Class II 1995-03-03
K950297 ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM Argus Medical Co., Inc. GCJ Class II 1995-03-03
K945953 GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE) W. L. Gore & Associates, Inc. GCJ Class II 1995-03-03
K950732 MANAN SUPER-CORE BIOPSY NEEDLE Manan Medical Products, Inc. KNW Class II 1995-03-02
K944387 R&D BATTERIES PART NOS. 5186 AND 5230 R & D Batteries, Inc. FCO Class I 1995-03-02
K943554 DOFI RASTER-SCREEN Howrey & Simon GCJ Class II 1995-03-01
K922217 FLEXIFLO NASOENTERIC FEEDING TUBE Abbott Laboratories KNT Class II 1995-03-01
K942918 TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER Tri-Med Specialties, Inc. OCX Class II 1995-02-28
K943143 BILIARY STENT Menlo Care, Inc. FGE Class II 1995-02-28
K942112 KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE Karl Storz Endoscopy FBN Class II 1995-02-28
K945136 RENAGUARD DIALYSATE FILTER Minntech Corp. FIP Class II 1995-02-28
K944390 R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 R & D Batteries, Inc. FCO Class I 1995-02-27
K945869 R&D PART NOS. 5443, 5322, 5448, 5492 R & D Batteries, Inc. FCO Class I 1995-02-27
K950109 CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER Cypress Medical Products, Ltd. FCM Class II 1995-02-27
K950092 CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY Cypress Medical Products, Ltd. FCM Class II 1995-02-27
K945871 R&D PART NOS. 5339, 5510, 5514 R & D Batteries, Inc. FCO Class I 1995-02-27
K921597 CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 Haemotronic, Inc. FJK Class II 1995-02-24
K943715 VISION SYSTEM UPPER G.I. EXDOSCOPE Vision-Sciences, Inc. FDS Class II 1995-02-24
K950503 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE United States Surgical, A Division of Tyco Healthc GCJ Class II 1995-02-24
K945012 CATCO NUTRITIONAL CATHETER Catco Medical, Inc. KNT Class II 1995-02-24
K950500 BASIC REUSABLE TROCAR SYSTEM Endoscopic Concepts, Inc. GCJ Class II 1995-02-23
K945862 ENDCUP Lewtek GCJ Class II 1995-02-23
K944062 LAPRASCOPIC GRASPER Instrument Makar, Inc. GCS Class II 1995-02-23
K945266 OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES Optus, Inc. GCJ Class II 1995-02-23
K940548 MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE Medical Innovations Corp. KNT Class II 1995-02-22
K950166 OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE Olympus America, Inc. KNS Class II 1995-02-22
K945890 KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KARL STORZ KNOT TIER KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-02-17
K946293 MILL-ROSE SCOPE CLEANING BRUSH Mill-Rose Laboratory MNL Class I 1995-02-16
K941543 DIAL MEDICAL KIT Regulatory & Marketing Services, Inc. KOC Class II 1995-02-16
K945258 CATCO URINARY COLLECTION KIT Catco Medical, Inc. FCN Class II 1995-02-16
K950559 DIENER RETRIEVAL DEVICES Mill-Rose Laboratory FCL Class I 1995-02-16
K944384 ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG Regulatory & Marketing Services, Inc. FGM Class I 1995-02-15
K944379 ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG Regulatory & Marketing Services, Inc. FGM Class I 1995-02-15
K944378 ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG Regulatory & Marketing Services, Inc. FGM Class I 1995-02-15
K945686 KARL STORZ KNIVES, CURETTES KARL STORZ Endoscopy-America, Inc. EZO Class II 1995-02-13
K922757 SPS 1550 SINGLE NEEDLE PATIENT SYSTEM Baxter Healthcare Corp FKP Class II 1995-02-13
K926372 MCA 200 HEMPDIALYZER Althin Medical AB an Affiliate of Baxter Intl FJI Class II 1995-02-13
K950336 KARL STORZ ADAPTERS FOR DOCUMENTATION PURPOSES KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-02-13
K935844 GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA Medi-Globe Corp. FCG Class II 1995-02-13
K933596 GASTRIC, CATHETER, IRRIGATION & ASPIRATION Polamedco, Inc. BSS Class II 1995-02-13
K926379 ALTRA NOVA 200 HEMODAILYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-02-13
K946243 CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER Coloplast A/S EXJ Class I 1995-02-13
K926373 ALTRA FLUX 200 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-02-13
K945591 APPLIED MEDICAL OPTICAL VALVULOTOME Applied Medical Resources LYK Class II 1995-02-10
K950198 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE United States Surgical, A Division of Tyco Healthc GCJ Class II 1995-02-09
K945495 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION Fiberoptic Sensor Technlogies, Inc. EXY Class II 1995-02-09
K950378 ARGUS LAPAROSCOPY INSTRUMENT SYSTEM Argus Medical Co., Inc. GCJ Class II 1995-02-09
K941013 HMT ALEXCOPE Servicetrends, Inc. FGB Class II 1995-02-09
K943250 LIBERTY Utah Medical Products, Inc. KPI Class II 1995-02-09
K944391 OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM Surgitek FEN Class II 1995-02-07
K945813 BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP Bd Becton Dickinson Vacutainer Systems Preanalytic FCG Class II 1995-02-07
K945210 KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP KARL STORZ Endoscopy-America, Inc. LJH Class II 1995-02-07
K950176 PREMIE U-BAG URINE SPECIMEN COLLECTOR Hollister, Inc. FOC Class II 1995-02-07
K945088 GABRIEL URETERAL ILLUMINATOR SYSTEM II Gabriel Medical, Inc. FCS Class II 1995-02-07

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