meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
58
Latest Decision
1989-12-21

Clearances · page 87 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K894869 WILTEK POLYPECTOMY SNARE Wiltek Medical, Inc. FDI Class II 1989-12-21
K894863 WILTEK CYTOLOGY BRUSH Wiltek Medical, Inc. FDX Class II 1989-12-21
K894860 WILTEK GASTRIC FEEDING TUBE Wiltek Medical, Inc. FPD Class II 1989-12-21
K894866 WILTEK STONE EXTRACTOR Wiltek Medical, Inc. LQR Class II 1989-12-21
K894867 WILTEK E.R.C.P. CATHETER Wiltek Medical, Inc. FGE Class II 1989-12-21
K894653 NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR Superior Biosystems, Inc. KGC Class II 1989-12-21
K894871 WILTEK BILIARY STENT SET Wiltek Medical, Inc. FGE Class II 1989-12-21
K896169 METAL URETERAL BASKET STONE DISLODGER Annex Medical, Inc. FFL Class II 1989-12-18
K894925 AMCATH URETERAL DILATORS MODELS 7100,7110,7120 Intec Medical, Inc. EZN Class II 1989-12-13
K895199 BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE Baxter Healthcare Corp KPO Class II 1989-12-13
K884920 RECTUM-COLON MOTILITY MONITOR Multi-Spectrum Consulting, Inc. FAP Class II 1989-12-08
K894939 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY North American Sterilization & Packaging Co. FPD Class II 1989-12-08
K896069 WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT Wilson-Cook Medical, Inc. FGE Class II 1989-12-08
K896163 SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO. Schneider Stent FGE Class II 1989-12-01
K894986 3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET North American Sterilization & Packaging Co. OCZ Class II 1989-12-01
K896537 PORGES HOT BIOPSY FORCEPS Porges Corp. KGE Class II 1989-11-30
K890310 STERILE FOLEY CATHETER Kosan Far East Ent. , Ltd. EYC Class II 1989-11-30
K891239 MOP CATHETER Bivona Medical Technologies KDL Class II 1989-11-28
K895336 ABBOTT INPERSOL CYCLER 1000 Abbott Laboratories FKX Class II 1989-11-28
K895856 MEDISYSTEMS TRANSDUCER PROTECTOR Medisystems Corp. FIB Class II 1989-11-24
K894794 AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP Vitaid, Ltd. KPM Class II 1989-11-21
K892855 URETHRAL BALLOON DILATION CATHETER SET Cook Urological, Inc. KOE Class II 1989-11-17
K895251 BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) C.R. Bard, Inc. KPN Class II 1989-11-13
K895281 TRANSDUCER PROTECTOR Filtertek, Inc. FIB Class II 1989-11-08
K894106 DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST Cd Medical, Inc. FIP Class II 1989-11-08
K894968 ULTRACOMPACT Eutectic Electronics, Inc. EXY Class II 1989-11-08
K895759 HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H National Medical Care, Medical Products Div., Inc. KDI Class II 1989-11-08
K895725 BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES Interson Corp. FCG Class II 1989-11-06
K895457 MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES Advance Medical Designs, Inc. KNW Class II 1989-11-01
K895706 TUBING ORGANIZER 3t Products, Inc. KNT Class II 1989-10-31
K895182 ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY Advanced Surgical Intervention, Inc. FAJ Class II 1989-10-24
K895616 L.T.C. FEEDING TUBE Intl. Medical Marketing, Inc. KNT Class II 1989-10-24
K895957 L.T.C. 1000 URINARY DRAINAGE BAG Intl. Medical Marketing, Inc. KNX Class II 1989-10-24
K895346 DR. DRY Intellitech KPN Class II 1989-10-24
K894627 BT-338N ELECTRONIC CLINICAL THERMOMETER Integrated Display Technology, Ltd. FCI Class II 1989-10-23
K894704 2.5 FRENCH LITHOTRIPTOR ELECTRODE Northgate Research, Inc. FFK Class II 1989-10-18
K895897 MANAN PROSTATIC BIOPSY NEEDLE Manan Medical Products, Inc. FCG Class II 1989-10-18
K893540 VINYL BAG W/PUMP ADMINISTRATION SET Sandoz Nutrition KNT Class II 1989-10-17
K895643 MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM Orthoconcept, Inc. FDC Class II 1989-10-17
K893888 HOLLISTER FEEDING TUBE ATTACHMENT DEVICE Hollister, Inc. KNT Class II 1989-10-17
K893541 VINYL BAG W/GRAVITY ADMINISTRATION SET Sandoz Nutrition KNT Class II 1989-10-17
K894209 ENEMA KIT Ledins Herbal Healing Systems KPL Class II 1989-10-13
K895178 TECHNOMED PULSOLITH LASER SYSTEM Teknomed, Inc. FFK Class II 1989-10-06
K883960 GIPHY MONITOR Vascular Technology Incorporated FFT Class I 1989-10-04
K884915 DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER Dantec Electronics, Inc. FAP Class II 1989-10-04
K894357 VAS-CATH URETERAL STENT CATHETER Vas-Cath, Inc. FAD Class II 1989-10-03
K894857 PEDI-TUBE(R) STYLET Biosearch Medical Products, Inc. KNT Class II 1989-10-03
K892252 BIOPSY FORCEPS Zinnanti Surgical Instruments, Inc. FCL Class I 1989-10-03
K894756 DENVER PERITONEO-VENUS SHUNT Codman & Shurtleff, Inc. KPM Class II 1989-09-29
K884715 ACHELASIA BALLOON DIALATOR Primrose Medical, Inc. KNQ Class II 1989-09-29
K892145 FIBER OPTIC LIGHT TRANSMISSION CABLE Opto Vision, Inc. FFS Class II 1989-09-29
K884714 BILIARY DIALATOR Primrose Medical, Inc. FGE Class II 1989-09-29
K884713 COLONIC BALLOON DIALATORS Primrose Medical, Inc. FFP Class I 1989-09-29
K884711 URETHRAL AND URETERAL BALLOON DILATATORS Primrose Medical, Inc. EZN Class II 1989-09-29
K891588 TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE) Ideal Medical, Inc. LQR Class II 1989-09-28
K885220 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT Ethox Corp. KNT Class II 1989-09-25
K892895 MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM Everest Medical Corp. KNS Class II 1989-09-25
K894637 NATIONAL MEDICAL CARE VENOUS LINE 03-9548 National Medical Care, Medical Products Div., Inc. KOC Class II 1989-09-22
K890400 MODIFIED URINARY CATHETER INTRODUCER (UCI) Go Medical Industries Pty. , Ltd. KOD Class II 1989-09-12
K893992 NOETIX, BIOPSY NEEDLE Noetix, Inc. KNW Class II 1989-09-08
K894419 GASTRO ENTEROLOGICAL BIOPTOME Symbiosis Corp. KNW Class II 1989-09-08
K894592 LAMANO DIRECTORS Marlo Surgical Technology GCM Class II 1989-09-08
K893553 BIPOLAR ELECTROSURGICAL SNARE Everest Medical Corp. FDI Class II 1989-09-08
K884712 ESOPHAGEAL AND PYLORIC BALLOON DIALATORS Primrose Medical, Inc. KNQ Class II 1989-09-08
K885168 RUBENSTEIN URETERAL STONE FRAGMENT BRUSH Boston Scientific Corp FGO Class II 1989-09-08
K884709 ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) Primrose Medical, Inc. ODD Class II 1989-09-08
K894838 HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB Baxter Healthcare Corp FKP Class II 1989-09-07
K894783 PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP Baxter Healthcare Corp KDJ Class II 1989-09-07
K893390 MODIFIED PRISTINE CULTURE CATHETER Hml Medical, Inc. KOD Class II 1989-09-07
K893729 HOBBS MEDICAL MICROBIOLOGY BRUSH Hobbs Medical, Inc. FDX Class II 1989-08-28
K894716 DIRECTABLE COAXIAL CATHETER SET Cook Ob/Gyn GCJ Class II 1989-08-23
K891773 MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI Hollister, Inc. KPI Class II 1989-08-23
K894363 UROPUMP* FLUID MANAGEMENT SYSTEM Orthoconcept, Inc. FDC Class II 1989-08-11
K893827 PEAK FLOW RATE METER Laytech Medical Co. FFG Class II 1989-08-11
K892069 EXTENDED COVERS, STERILE Amedic USA FFF Class I 1989-08-08
K892071 GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE Amedic USA KNW Class II 1989-08-08
K892068 TRT (ACUSON) NEEDLE GUIDE KIT, STERILE Amedic USA FCG Class II 1989-08-04
K891371 GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG Entech, Inc. KNT Class II 1989-08-03
K890402 MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) Mentor Corp. FAE Class II 1989-08-03
K891585 HYDRO-SAN COLONIC IRRIGATION SYSTEM Specialty Health Products, Inc. KPL Class II 1989-08-03
K873295 PROSTATIC URETHRO. BALLOON DILATATION CATHETER Medi-Tech, Inc. KOE Class II 1989-07-31
K893440 FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 Welch Allyn, Inc. FFS Class II 1989-07-28
K893679 SHUNT CONNECTORS Akcess Medical Products, Inc. FJQ Class I 1989-07-24
K893712 PERITONEAL DIALYSIS SYSTEM AND ACCESS. Delmed, Inc. KDJ Class II 1989-07-24
K893612 TWO TANK DISSOLUTION MODULE National Medical Care, Medical Products Div., Inc. FKQ Class II 1989-07-24
K893742 FILTRAL TM 20 HEMODIALYZER/FILTER Hospal Medical Corp. KDI Class II 1989-07-24
K893677 HOLLOW FIBER DIALYZER FOCUS 70H National Medical Care, Medical Products Div., Inc. FJI Class II 1989-07-24
K890093 PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET Kells Medical, Inc. KNT Class II 1989-07-24
K893209 ENTERA-FLO SPIKE SET Delmed, Inc. KNT Class II 1989-07-24
K890096 BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG Medical Inventors Corp., Inc. FCN Class II 1989-07-14
K892436 KENDALL CURITY IRRIGATION SYRINGE The Kendal Co. KOD Class II 1989-07-14
K892437 KENDALL KENGUARD URINARY LEG BAGS The Kendal Co. KNX Class II 1989-06-23
K891352 MARLOW ANAL SPECULUM Simpson/Basye, Inc. KOA Class I 1989-06-23
K892691 CATHETERS, MALE, FEMALE Zinnanti Surgical Instruments, Inc. KOD Class II 1989-06-23
K892439 KENDALL CURITY STOMACH TUBES The Kendal Co. KNT Class II 1989-06-23
K892442 KENDALL CURITY URETHRAL CATHETERS The Kendal Co. GBM Class II 1989-06-23
K891410 NASOGASTRIC PH SUCTION CATHETER, ST-5001 Sensatronix Medical Systems, Inc. FFT Class I 1989-06-23
K892932 BIOPRIME TM KIT Hospal FJK Class II 1989-06-22
K893531 CUFF SPECULUM Mountain Medical Equipment, Inc. KPL Class II 1989-06-22
K892426 NO. 86500 - ENDOSCOPIC JET WASHER Superior Healthcare Group, Inc. OCX Class II 1989-06-22

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