meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
53
Latest Decision
1996-03-26

Clearances · page 63 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960007 STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR Storz MPA Class II 1996-03-26
K954043 MANAN BILIARY DRAINAGE CATHETER Manan Medical Products, Inc. FGE Class II 1996-03-26
K954147 MANAN MALECOT BASKET DRAINAGE CATHETER Manan Medical Products, Inc. FEW Class II 1996-03-26
K960148 CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT Cabot Medical Corp. FAD Class II 1996-03-25
K951579 EC-3800TL, VIDEO COLONOSCOPE Pentax Precision Instrument Corp. FDF Class II 1996-03-21
K951577 ES-3800, VIDEO SIGMOIDOSCOPE Pentax Precision Instrument Corp. FAM Class II 1996-03-21
K960232 ENDOSCOPIC ACCESS DEVICE Applied Medical Technologies GCJ Class II 1996-03-21
K951574 EC-3800L, VIDEO COLONOSCOPE Pentax Precision Instrument Corp. FDF Class II 1996-03-21
K960883 INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 Taut, Inc. GCJ Class II 1996-03-20
K960004 CELL RECOVERY SYSTEM Medical Device Technologies, Inc. FDX Class II 1996-03-20
K960878 MAHLER ABDOMINAL WALL ELEVATOR Cook Urological, Inc. GCJ Class II 1996-03-15
K960317 LAURUS NEEDLE CORE BIOPSY SYSTEM Laurus Medical Corp. FCG Class II 1996-03-15
K960081 BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE Mitsubishi Cable America, Inc. FCQ Class II 1996-03-12
K955338 DRYTIME FOR POTTY TRAINING Health Sense Intl., Inc. KPN Class II 1996-03-12
K960400 DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) Snowden-Pencer FBM Class I 1996-03-12
K953854 WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE Integrated Biomedical Technology, Inc. FKP Class II 1996-03-11
K954429 KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT Sherwood Medical Co. KNT Class II 1996-03-08
K960828 POS-T-VAC B-10 BAND KIT Pos-T-Vac, Inc. LKY Class II 1996-03-08
K954704 VS-200 VIDEO SIGMOIDOSCOPE Welch Allyn, Inc. FDF Class II 1996-03-07
K960342 POS-T-VAC AVP-1000 & MVP-700 Pos-T-Vac, Inc. LKY Class II 1996-03-01
K954527 ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS Rockwell Medical Supply KPO Class II 1996-03-01
K952262 SPEEDBAND Boston Scientific Corp FHN Class II 1996-02-29
K960566 NHMC FOLEY CATHETERIZATION TRAY National Healthcare Mfg. Corp. FCM Class II 1996-02-29
K955298 PHOENIX DIALYSATE METER Automata Medical Instrumentation, Inc. FIZ Class II 1996-02-29
K955558 GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES Medi-Globe Corp. FBK Class II 1996-02-29
K960011 ENDOSCOPIC NEEDLE DRIVER United States Surgical, A Division of Tyco Healthc OCW Class II 1996-02-21
K955531 ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM Arthrocare Corp. FAS Class II 1996-02-21
K944493 REVERSE OSMOSIS SYSTEM G.E.M. Water Systems FIP Class II 1996-02-20
K955277 ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS Baxter Healthcare Corp KOC Class II 1996-02-16
K955856 TEX-AID BLUE Laborie Medical Technologies, Ltd. LKY Class II 1996-02-16
K953751 BIOLOGIC-DT SYSTEM Hemocleanse, Inc. FLD Class II 1996-02-15
K954864 ASLAN MODULAR INSTRUMENT Aslan Medical Technologies, Ltd. GCJ Class II 1996-02-09
K955413 ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER Endovations FGE Class II 1996-02-08
K953419 LOS 3D VISION 100 Laser Optik Systeme GmbH & Co. KG GCJ Class II 1996-02-08
K950087 LOT 440 Medical Instruments Corporation Mic AG FFT Class I 1996-02-06
K955404 OTV-S5 OES VIDEO SYSTEM Olympus America, Inc. GCJ Class II 1996-02-01
K955408 MICROSURGE THORACOSCOPIC INSTRUMENTS Microsurge, Inc. GCJ Class II 1996-01-31
K955018 TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR Instrumentarium Corp. FFT Class I 1996-01-30
K944436 COBE CENTRYSYSTEM CS 200 DIALYZER Cobe Renal Care, Inc. FJI Class II 1996-01-29
K955120 HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR Ethicon Endo-Surgery, Inc. GCM Class II 1996-01-26
K955066 OLYMPUS FG SERIES GRASPING FORCEPS Olympus America, Inc. OCZ Class II 1996-01-25
K954972 LYELL SOUND Venture Management Corp. FBS Class I 1996-01-24
K955810 U-TEX Laborie Medical Technologies, Ltd. FHA Class I 1996-01-24
K955065 OLYMPUS FB SERIES BIOPSY FORCEPS Olympus America, Inc. FCL Class I 1996-01-24
K954928 PORTABLE REVERSE OSMOSIS MACHINE Better Water, Inc. FIP Class II 1996-01-24
K955052 OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS Olympus America, Inc. KGE Class II 1996-01-24
K941867 RENALIN REUSE CART Renal Scientific Service, Inc. LIF Class II 1996-01-22
K955063 OLYMPUS BASKET GRASPERS Olympus America, Inc. OCZ Class II 1996-01-22
K954776 REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY United States Endoscopy Group, Inc. KNT Class II 1996-01-22
K952959 THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK The Tulip Mfg. Co. GCJ Class II 1996-01-22
K955490 LAPAROSCOPIC KNITTER Core Dynamics, Inc. GCJ Class II 1996-01-22
K953967 ENDOSCOPIC CATHETER Act Medical, Inc. ODD Class II 1996-01-22
K952906 THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK The Tulip Mfg. Co. GCJ Class II 1996-01-22
K941757 FORMALIN REUSE CART National Medical Care, Medical Products Div., Inc. LIF Class II 1996-01-22
K953734 LUMAX(MODIFICATION) Medamicus, Inc. FEN Class II 1996-01-18
K955051 OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS Olympus America, Inc. OCZ Class II 1996-01-18
K953453 SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES Symbiosis Corp. FAS Class II 1996-01-17
K953008 INFANT FEEDING TUBE Marquette Medical, Inc. FPD Class II 1996-01-11
K951311 GAMBRO HC 14R HEMOCONCENTRATOR Cobe Renal Care, Inc. KDI Class II 1996-01-11
K954093 LUMAX (MODIFICATION) Medamicus, Inc. FEN Class II 1996-01-11
K952572 DIALYSIS ADMINISTRATION KITS B.Braun Medical, Inc. KOC Class II 1996-01-11
K952581 GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR Gamp & Assoc. MPA Class II 1996-01-05
K952585 GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR Gamp & Assoc. MPA Class II 1996-01-05
K954529 AUTOMATED TRU-CUT BIOPSY DEVICE Baxter Healthcare Corp KNW Class II 1995-12-29
K955609 CONVEEN URINE BAG - STERILE Coloplast Corp. FAQ Class I 1995-12-29
K954641 ENDO-LEADER Microsurge, Inc. OCW Class II 1995-12-28
K954519 WANG TRANSENDOSCOPIC ASPIRATION NEEDLE Mill-Rose Laboratory FBK Class II 1995-12-22
K952343 FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER National Medical Care, Medical Products Div., Inc. FJI Class II 1995-12-22
K954649 WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP Wilson Greatbatch Technologies, Inc. GCJ Class II 1995-12-22
K953767 PROSYS BEDSIDE DRAINAGE BAG Convatec, A Division of E.R. Squibb & Sons FAQ Class I 1995-12-20
K943304 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY Olympus America, Inc. FCG Class II 1995-12-20
K943307 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY Olympus America, Inc. GCJ Class II 1995-12-20
K954853 AUTO SUTURE SUTURE CLOSURE United States Surgical, A Division of Tyco Healthc GCJ Class II 1995-12-20
K951600 MILL-ROSE ROTATABLE POLYPECTOMY SNARE Mill-Rose Laboratory FDI Class II 1995-12-18
K945066 AWESMOSIS Applied Water Engineering, Inc. FIP Class II 1995-12-15
K954349 FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS Minntech Corp. FIP Class II 1995-12-15
K955049 OLYMPUS FG-45/46-1 GRASPING FORCEPS Olympus America, Inc. FFL Class II 1995-12-15
K950042 SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER Accurate Surgical Instruments Co. FJS Class II 1995-12-15
K952780 URINARY GEL DRAINAGE SYSTEM P.A.M., Inc. EYZ Class I 1995-12-12
K946249 BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES C.R. Bard, Inc. KNT Class II 1995-12-11
K955479 KOH MICRO-SUTURING INSTRUMENTS KARL STORZ Endoscopy-America, Inc. OCW Class II 1995-12-08
K955019 UROTRACT I Dornier Medtech America, Inc. KQS Class I 1995-12-06
K954959 CAP-AID Nebl, Inc. FHA Class I 1995-12-06
K954160 MSV-2000 VIDEO IMAGING SYSTEM Applitec, Ltd. GCJ Class II 1995-12-04
K950602 PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS Reprocessing Products Corp FJI Class II 1995-11-30
K954315 PVC ABDOMINAL/RECTAL PRESSURE CATHETER Life-Tech Intl., Inc. FEN Class II 1995-11-30
K941992 CYSTOSCOPE Surgical Technologies, Inc. FBO Class II 1995-11-30
K930181 BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE Fresenius USA, Inc. FKP Class II 1995-11-29
K954536 BLADE, SCALPEL & BLADE, HANDEL Access Surgical Intl., Inc. OCZ Class II 1995-11-29
K944539 DRS 4 ND DIALYZER REPROCESSING SYSTEM Seratronics, Inc. LIF Class II 1995-11-29
K944767 DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER Fresenius USA, Inc. FIP Class II 1995-11-29
K954745 MILL-ROSE RIGID SCOPE CLEANING BRUSHES Mill-Rose Laboratory FEB Class II 1995-11-27
K953876 PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) Pentax Precision Instrument Corp. ODG Class II 1995-11-24
K944473 XCHF-33 CHOLEDOCHOFIBERSCOPE Olympus America, Inc. FBN Class II 1995-11-22
K954050 RESECTOSCOPES KARL STORZ Endoscopy-America, Inc. FJL Class II 1995-11-22
K922567 LOW PROFILE CATHETER Rusch, Inc. KNT Class II 1995-11-21
K946109 CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS Cabot Medical Corp. KNS Class II 1995-11-21
K953999 DANTEC DA CAPO Dantec Medical, Inc. EXY Class II 1995-11-21
K950247 TS 564/PF Bressler, Amery & Ross FJK Class II 1995-11-17
K951421 GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES Global Medical Products, Ltd. FCG Class II 1995-11-16

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