meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
1994-09-08

Clearances · page 70 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K943663 NAVARRE 600 ML DRAINAGE BAG Navarre Biomedical , Ltd. EXF Class II 1994-09-08
K932295 NON-BALLOON REPLACEMENT GASTROSTOMY KIT Biosearch Medical Products, Inc. KNT Class II 1994-09-08
K940427 KARL STORZ THORACIC SURGERY INSTRUMENTS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-09-07
K943976 SABRE ULTIMATE SHIELDED TROCAR Endoscopic Concepts, Inc. GCJ Class II 1994-09-07
K933681 GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS Cobe Renal Care, Inc. FJG Class II 1994-09-07
K943958 MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS Tnco, Inc. GCJ Class II 1994-09-07
K935737 STONE EXTRACTOR, GRASPING FORCEPS Boston Scientific Corp FFL Class II 1994-09-07
K915166 MICROCYCLER Medical Inventors Corp., Inc. FCN Class II 1994-09-07
K935163 CONTINUOUS IRRIGATION CYSTOURETHROSCOPE Richard Wolf Medical Instruments Corp. FBO Class II 1994-09-07
K934704 AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH United States Surgical, A Division of Tyco Healthc GCJ Class II 1994-09-06
K943970 DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE Cook Ob/Gyn GCJ Class II 1994-09-06
K930843 RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 National Medical Care, Medical Products Div., Inc. KDJ Class II 1994-08-31
K931763 HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS Olympus Corp. FAS Class II 1994-08-29
K943191 MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR Boston Scientific Corp LQC Class II 1994-08-29
K923529 DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES Seratronics, Inc. LIF Class II 1994-08-29
K942485 MDT UROLOGY TABLE Mdt Corp., Inc. MMZ Class II 1994-08-26
K943650 LIVER BIOPSY KIT Manan Medical Products, Inc. KNW Class II 1994-08-26
K935270 MODULAR FORCEP AND SCISSOR SYSTEM Richard Wolf Medical Instruments Corp. GCJ Class II 1994-08-26
K933680 GAMBRO LUNDIA PRO 200 DIALYZER Cobe Renal Care, Inc. FJG Class II 1994-08-26
K942817 CCD ENDOCAM OFFICE 5510 Richard Wolf Medical Instruments Corp. GCJ Class II 1994-08-25
K941027 ENDOPATH OPTICAL OBTURATOR AND SLEEVE Ethicon Endo-Surgery, Inc. GCJ Class II 1994-08-23
K942740 SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM Sharplan Lasers, Inc. GCJ Class II 1994-08-23
K942819 TROCAR WITH SHIELD Mahe-Medizintechnik GCJ Class II 1994-08-23
K922553 CLA-COMPUTERIZED LARYNGEAL ANALYZER H.I.L. Research, Ltd. KLA Class II 1994-08-23
K926005 FRESENIUS HEMOFLOW, VARIOUS MODELS Fresenius USA, Inc. FJI Class II 1994-08-23
K942885 AUTO SUTURE MODIFIED GRIP United States Surgical, A Division of Tyco Healthc FBQ Class II 1994-08-22
K935721 STONE EXTRACTOR Boston Scientific Corp FFL Class II 1994-08-22
K942703 GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA Gm Engineering, Inc. GCJ Class II 1994-08-19
K920780 MEDSURG INSERTION TRAY Medsurg Industries, Inc. LFJ Class II 1994-08-19
K935045 BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER Biosearch Medical Products, Inc. KNT Class II 1994-08-19
K942578 ENTRAC URETERAL BALLOON DILATATION CATHETERS American Medical Systems, Inc. EZN Class II 1994-08-19
K910318 BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER C.R. Bard, Inc. MJC Class II 1994-08-18
K941401 MILL ROSE ERCP CANNULAS Mill-Rose Lab, Inc. GCJ Class II 1994-08-17
K940370 AMERICAN CATHETER E.R.C.P. CANNULA Intl. Medical, Inc. FGE Class II 1994-08-17
K936195 LAPAROSCOPES Micromedical Devices, Inc. GCJ Class II 1994-08-17
K943737 MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE Boston Scientific Corp OCY Class II 1994-08-17
K942612 KARL STORZ WOUND CLOSURE INSTRUMENTS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-08-15
K942597 CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR Holmed Corp. GCJ Class II 1994-08-15
K941950 OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360 Baxter Healthcare Corp GCJ Class II 1994-08-11
K943624 ELMED PNEUMOPERITONEUM NEEDLES Henke-Sass, Wolf GmbH FHO Class II 1994-08-10
K943489 DISPOSABLE SURGICAL TROCAR Applied Medical Resources GCJ Class II 1994-08-09
K943671 GSI CANNULA REDUCER ACCESSORY General Surgical Innovations GCJ Class II 1994-08-09
K942358 AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA M.P. Video, Inc. GCJ Class II 1994-08-08
K941464 BASICS ENDOSCOPY SYSTEM Cox Medical Ent., Inc. OCZ Class II 1994-08-05
K920757 FILTRAL HEMODIALYZERS C.G.H. Medical, Inc. KDI Class II 1994-08-05
K943117 INTRA-SONIX UROFIBER Intra-Sonix, Inc. GCJ Class II 1994-08-04
K925819 AKCESS0CATH KIT Akcess Medical Products, Inc. LFJ Class II 1994-08-02
K943368 TRU-CORE NEEDLE SET Ideamatrix KNW Class II 1994-07-29
K923727 PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 Minntech Corp. KDI Class II 1994-07-29
K943172 CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR Core Dynamics, Inc. GCJ Class II 1994-07-28
K942057 FISHER-PRICE DRY NIGHT MONITOR Fisher Price KPN Class II 1994-07-28
K932293 CABOT MEDICAL BIPOLAR CUTTING FORCEPS Cabot Medical Corp. KNS Class II 1994-07-27
K942839 OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY Olympus America, Inc. GCJ Class II 1994-07-27
K942018 R&D BATTERIES, PART NO. 5025, 5128 AND 5183 R & D Batteries, Inc. FCO Class I 1994-07-25
K941087 POS-T-VAC-AVP-1000 Pos-T-Vac, Inc. LKY Class II 1994-07-25
K943070 REUSABLE PROBES Surgin Surgical Instrumentation, Inc. GCJ Class II 1994-07-22
K940335 AMERICAN CATHETER POLY-SNARE Intl. Medical, Inc. FDI Class II 1994-07-21
K940948 ANGLED DISSECTORS MODELS 8383.581/582/571 Richard Wolf Medical Instruments Corp. GCJ Class II 1994-07-21
K935243 AESCULAP FLEXIBLE TROCAR INSTRUMENT SET Aesculap, Inc. GCJ Class II 1994-07-21
K942677 GEENEN/ZEBRA GUIDELINES Boston Scientific Corp FDE Class II 1994-07-21
K942879 DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH Deroyal Industries, Inc. GCJ Class II 1994-07-19
K941447 SIMPLA S4, S5, S7 Simpla Plastics , Ltd. KNX Class II 1994-07-18
K942573 COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH Richard Hamer Assoc., Inc. FED Class II 1994-07-18
K941773 MEDICAM 900 REMOTE M.P. Video, Inc. GCJ Class II 1994-07-18
K941816 EMC FLEXIBLE BIOPSY FORCEPS Enterprise Medical Corp. FCL Class I 1994-07-13
K935818 ENDOSCOPE Cuda Products Co. GDB Class II 1994-07-13
K941256 QUICK CORE II Proact, Ltd. KNW Class II 1994-07-13
K942023 INFUSION PUMP, MODEL NO. UDP-5 Laborie Medical Technologies, Ltd. FEN Class II 1994-07-12
K942630 WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE Mill-Rose Laboratory KNW Class II 1994-07-12
K941359 GIP/MEDI-GLOBE BIOPSY FORCEPS Medi-Globe Corp. FCL Class I 1994-07-12
K942678 LIFTING DISTENTION BALLOON SYSTEM Origin Medsystems, Inc. GCJ Class II 1994-07-08
K933906 CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION Fujinon, Inc. FBN Class II 1994-07-08
K920579 LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE Wilson-Cook Medical, Inc. KNT Class II 1994-07-08
K942641 SURGIN IRRIGATION PUMP Surgin Surgical Instrumentation, Inc. GCJ Class II 1994-07-07
K931720 LUNDIA ALPHA 700 HEMODIALYZER C.G.H. Medical, Inc. KDI Class II 1994-07-07
K941249 SPECIMEN REMOVAL DEVICE General Surgical Innovations GCJ Class II 1994-07-07
K942491 ORIGIN BALLOON RETRACTOR Origin Medsystems, Inc. GCJ Class II 1994-07-07
K935659 BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST Baxter Healthcare Corp FKX Class II 1994-07-07
K942205 ZEBRA UROLOGICAL GUIDEWIRE Boston Scientific Corp KNY Class II 1994-07-07
K942639 BIOPSY NEEDLE AND HOUSING Biopsys Medical, Inc. KNW Class II 1994-07-07
K942576 CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE White Knight Healthcare OCT Class II 1994-07-05
K942636 PSB PREPERITONEAL STRUCTURE BALLOON Origin Medsystems, Inc. GCJ Class II 1994-07-01
K930581 E-Z-FLATE E-Z-Em, Inc. FCX Class II 1994-07-01
K942155 HMT ENDOSCREEN, MODEL ESC 501 Servicetrends, Inc. FCW Class II 1994-07-01
K936262 DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS Medicon Instruments, Inc. GCJ Class II 1994-07-01
K941747 SURGISTAR TROCARS Surgistar, Inc. GCJ Class II 1994-07-01
K930224 STRYKER ARTHROSCOPIC ACCESSORIES Stryker Corp. GCJ Class II 1994-06-30
K923002 ENTEROCLYSIS TUBE Biosearch Medical Products, Inc. KNT Class II 1994-06-28
K941693 MEDICAM ENDOCOUPLER AND BEAMSPLITTER M.P. Video, Inc. GCJ Class II 1994-06-27
K925061 HELLER TRANSILLUMINATING STYLETTE Device Resources KNT Class II 1994-06-27
K941728 MONOPOLAR COAGULATING POLYPECTOMY SNARE Endoscopic Innovations, Inc. KNS Class II 1994-06-27
K942144 URETHRA-BRUSH Rovers Diagnostic Devices FDX Class II 1994-06-27
K924437 HEMOSPAL KIT B22 / MULTIFLOW 60 KIT C.G.H. Medical, Inc. KDI Class II 1994-06-27
K942030 BIOPSY SCISSORS Surgical Technologies, Inc. OCZ Class II 1994-06-27
K941779 KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE KARL STORZ Endoscopy-America, Inc. FAJ Class II 1994-06-27
K942484 VERRES NEEDLE Linvatec Corp. FHO Class II 1994-06-24
K942074 FLEXFINDER GUIDEWIRE Flexmedics KNY Class II 1994-06-24
K940464 KARL STORZ URETERO-RENOSCOPE/URETERSCOPE KARL STORZ Endoscopy-America, Inc. FGB Class II 1994-06-24
K935278 KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE KARL STORZ Endoscopy-America, Inc. FAJ Class II 1994-06-24
K942068 AMERICAN CATHETER SPHINCTEROTOME Intl. Medical, Inc. KNS Class II 1994-06-24

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