meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
47
Latest Decision
1995-08-28

Clearances · page 65 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945480 MOSS(R) STEEL BREAKAWAY(R) INTRODUCER Harry A. Schlakman KOB Class II 1995-08-28
K953243 LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH Devmed Group, Inc. GCJ Class II 1995-08-28
K944492 DIALYZER REPROCESSING SYSTEM G.E.M. Water Systems LIF Class II 1995-08-28
K951863 ROLLER ELECTRODE Olympus America, Inc. FAS Class II 1995-08-24
K952583 AQUISEN Aquintel, Inc. LJH Class II 1995-08-24
K951442 FLOLAB Synectics Medical, Inc. EXY Class II 1995-08-24
K924695 ASEPTECH PORTABLE RO+ SYSTEM Dayton Water Systems FIP Class II 1995-08-24
K951531 SWISS LITHOCLAST LITHOTRIPTER Electro Medical Systems SA FFK Class II 1995-08-24
K953549 KSEA EXTRACTION BAG KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-08-21
K953024 LINDNER/GOLOMB SP INTRODUCING SOUND Cook Urological, Inc. KOB Class II 1995-08-18
K952841 THE ASSISTANT Apple Medical Corp. FHA Class I 1995-08-18
K953441 RIZA-RIBE NEEDLE R-Med, Inc. FBK Class II 1995-08-18
K952924 ADI CATHETER WITH VALVE Asia Dynamics, Inc. GBM Class II 1995-08-18
K953232 HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE Hollister, Inc. KNT Class II 1995-08-18
K951855 ULTRATHIN URETEROSCOPES Olympus America, Inc. FGB Class II 1995-08-16
K953509 BIPOLAR COAGULATING FORCEPS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-08-16
K953481 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER American Hydro-Surgical Instruments, Inc. GCJ Class II 1995-08-16
K943801 URIGLOW TRANSILLUMINATING URETERIC STENT MODEL Rocket of London, Ltd. FCS Class II 1995-08-15
K952208 PROSYS LEG BAG Convatec, A Division of E.R. Squibb & Sons KNX Class II 1995-08-15
K951344 RMI HEMOCONCENTRATOR Research Medical, Inc. KDI Class II 1995-08-15
K953561 PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) Origin Medsystems, Inc. GCJ Class II 1995-08-11
K952215 SERIM HISENSE TEST KIT Serim Research Corp. FIP Class II 1995-08-09
K952443 KARL STORZ ENDOSCOPY POWDER BLOWER KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-08-09
K952278 THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA General Surgical Innovations GCJ Class II 1995-08-07
K952444 SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA Adjacent Surgical, Inc. GCJ Class II 1995-08-07
K951597 URINARY DRAINAGE BAG Key Medical Services, Inc. EYZ Class I 1995-08-04
K946080 PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR Portable Power Systems, Inc. FCO Class I 1995-08-02
K953201 IMAGYN UROSCOPE Imagyn Medical, Inc. FAJ Class II 1995-08-02
K953338 INJECTION NEEDLE Boston Scientific Corp FBK Class II 1995-08-02
K944051 ABSORBALBE ANCHOR Mitek Surgical Products, Inc. MNV Class II 1995-08-02
K950429 VIDEO SIGMOIDOSCOPE Welch Allyn, Inc. FAM Class II 1995-08-01
K952842 ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE Ethicon Endo-Surgery, Inc. GCJ Class II 1995-07-31
K952926 QUESTUS DISPOSABLE ENDOSCOPIC KNIFE Wrightmedicaltechnologyinc GCJ Class II 1995-07-31
K952691 WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT Welch Allyn, Inc. FJC Class II 1995-07-31
K952638 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ Baxter Edwards LYK Class II 1995-07-28
K952028 COLD LIGHT SOURCE LOS XL-A 100 Laser-Optik-Systeme GmbH & Co. KG GCT Class II 1995-07-27
K952785 BRIMFIELD PRECISION DETACHABLE SCISSOR Springfield Surgical Instruments GCJ Class II 1995-07-26
K952563 THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM The Tulip Mfg. Co. GCT Class II 1995-07-25
K952696 XENON LIGHT SOURCE MODEL 5121 Richard Wolf Medical Instruments Corp. GCT Class II 1995-07-25
K952187 RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE Rusch, Inc. KOB Class II 1995-07-25
K950417 EPX-310 VIDEO PROCESSOR (ENDOSCOPY) Marks & Murase FET Class II 1995-07-21
K942910 DEEPVISON Automated Medical Products Corp. GCJ Class II 1995-07-21
K951972 CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS Cabot Medical Corp. FBO Class II 1995-07-21
K923488 GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY Applied Medical Technologies KNT Class II 1995-07-20
K952574 KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS KARL STORZ Endoscopy-America, Inc. FJL Class II 1995-07-20
K952656 XXL BALLOON DILATATION CATHETER Boston Scientific Corp KNQ Class II 1995-07-19
K952863 FORCEPS, BIOPSY, NON-ELECTRIC Annex Medical, Inc. FCL Class I 1995-07-19
K951532 METAL URETERAL BASKET STONE DISLODGER Annex Medical, Inc. FFL Class II 1995-07-19
K951897 POWER RESECTOSCOPE CUTTING LOOP Power Analytics Corp. FAS Class II 1995-07-18
K952082 ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER Rochester Medical Corp. EXJ Class I 1995-07-18
K952977 SABRE MULTI-USE TROCAR SYSTEM Endoscopic Concepts, Inc. GCJ Class II 1995-07-17
K952723 DEVMED REUSEABLE TROCAR SYSTEM Devmed Group, Inc. GCJ Class II 1995-07-11
K951721 APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE Applied Medical Resources LYK Class II 1995-07-11
K952814 ETHICON ARTHROSCOPIC KNOT PUSHER ETHICON, Inc. GCJ Class II 1995-07-11
K951090 INTRODUCER Ranfac, Corp. GCJ Class II 1995-07-11
K945628 CLEAR ADVANTAGE II Mentor Corp. EXJ Class I 1995-07-06
K951805 PIPER, MODEL NUMBER UDS-PIPERB Laborie Medical Technologies, Ltd. FEN Class II 1995-07-06
K951716 AMS 650 MALLERABLE PENIEL PROSTHESIS American Medical Systems, Inc. FAE Class II 1995-07-06
K951533 EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT Ballard Medical Products KDH Class II 1995-07-05
K941973 GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES Medi-Globe Corp. FGE Class II 1995-06-30
K951386 COMBINATION CAMERA/LIGHT SOURCE M.P. Video, Inc. GCJ Class II 1995-06-30
K951878 SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA General Surgical Innovations GCJ Class II 1995-06-29
K944007 EUROPHILIC SLIPPERY COATED FOLEY CATHETER Baxter Healthcare Corp EZL Class II 1995-06-29
K951576 FS-34P2, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. FAM Class II 1995-06-29
K951573 FS-38H, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. FAM Class II 1995-06-27
K951575 FC-38TLH, FIBER COLONOSCOPE Pentax Precision Instrument Corp. FDF Class II 1995-06-27
K951578 FC-38LX, FIBER COLONOSCOPE Pentax Precision Instrument Corp. FDF Class II 1995-06-27
K951580 FC-38LH, FIBER COLONOSCCOPE Pentax Precision Instrument Corp. FDF Class II 1995-06-27
K951572 FS-38X, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. FAM Class II 1995-06-27
K952414 PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER Acacia Laboratories, Inc. KNY Class II 1995-06-23
K915402 EW-10 AND EW-20 Olympus Corp. FEB Class II 1995-06-23
K942681 FILTRYZER Toray Industries (America), Inc. KDI Class II 1995-06-22
K951546 ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS Ethicon Endo-Surgery, Inc. GCJ Class II 1995-06-21
K932033 LAPAROSCOPIC SURGERY INSTRUMENTS Medline GCJ Class II 1995-06-19
K951522 WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA Woodbine Optical Corp. GCJ Class II 1995-06-16
K951443 STANDARD FOLEY SYSTEM PAK Trinity Laboratories, Inc. FCN Class II 1995-06-15
K951894 ACCESS EXPANSION SYSTEM Micro-Medical Devices, Inc. FHO Class II 1995-06-15
K951479 CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE Trinity Laboratories, Inc. FCM Class II 1995-06-15
K952149 KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS KARL STORZ Endoscopy-America, Inc. LQR Class II 1995-06-15
K952573 RUSCH URODYNAMIC RECTAL BALLOON CATHETER Rusch Intl. FEN Class II 1995-06-15
K944912 OLYMPUS NBD TUBES Olympus America, Inc. FGE Class II 1995-06-13
K920186 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Better Water, Inc. FIP Class II 1995-06-13
K945069 FLEXILOG 2000 Oakfield Instruments, Ltd. FFT Class I 1995-06-13
K952029 RUSCH INTERNATIONAL URODYNAMIC CATHETERS Rusch Intl. FEN Class II 1995-06-13
K952264 ASLAN LAPRETRACT Aslan Medical Technologies, Ltd. GCJ Class II 1995-06-12
K931921 CORPAK GASTROSTOMY TUBE Corpak Co. KNT Class II 1995-06-09
K951986 INSULATED ELECTROSURGICAL INSTRUMENTS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1995-06-09
K952421 NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS American Hydro-Surgical Instruments, Inc. GCJ Class II 1995-06-08
K951489 MRI'S ALL SILICONE GASTROSTOMY TUBE Manufacturing & Research, Inc. KNT Class II 1995-06-07
K932880 GRASSI GASTROJEJUNOSTOMY TUBE Bissell Medical Products, Inc. KNT Class II 1995-06-07
K951569 SURGACTIVATOR Deschutes Medical Products, Inc. LJH Class II 1995-06-06
K952391 DYNABITE UROLOGICAL FORCEPS Portlyn Corp. FCL Class I 1995-06-01
K951733 NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS American Hydro-Surgical Instruments, Inc. GCJ Class II 1995-05-31
K950390 URETHRAL CATHETERIZATION TRAY Medcare Custom Packaging, Inc. FCM Class II 1995-05-30
K951197 FE-24X, FIBER ESOPHAGOSCOPE Pentax Precision Instrument Corp. GCL Class II 1995-05-30
K945621 ALTRA NOVA(TM) 170 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-05-30
K951198 FE-34TH, FIBER ESOPHAGOSCOPE Pentax Precision Instrument Corp. GCL Class II 1995-05-30
K945625 ALTRA NOVA(TM) 140 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1995-05-30
K951191 FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE Pentax Precision Instrument Corp. FBN Class II 1995-05-30
K942626 CONTINUOUS FLOW BIOPSY PROBE Gm Engineering, Inc. FDC Class II 1995-05-30

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