meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
36
Latest Decision
1994-06-23

Clearances · page 71 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K930175 CATH BELT PD CATHETER AND TRANSFER SET HOLDER Tabex Industries, Inc. FJS Class II 1994-06-23
K942584 PUTMAN STABILIZER J. Michael Putman, M.D., P.A. GCJ Class II 1994-06-23
K934835 FLOVAL Olympus Corp. FJL Class II 1994-06-21
K942414 TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE Linvatec Corp. GCJ Class II 1994-06-21
K941230 MINI-UB ENDOSCOPES Candela Laser Corp. ODF Class II 1994-06-17
K923168 DUAL PORT ENTERAL Y-ADAPTOR Orion Life Systems, Inc. KNT Class II 1994-06-17
K941919 OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM Oktas FET Class II 1994-06-17
K940995 RELIANT CONSTRICTION RING Walling Medical Equipment Co. LKY Class II 1994-06-14
K941011 ACU-SIZER(TM) Applied Medical Resources EYB Class II 1994-06-13
K942415 R-BAR RETRACTOR Linvatec Corp. GCJ Class II 1994-06-13
K933750 MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF Microsurge, Inc. GCJ Class II 1994-06-10
K940988 ACCESSORIES, SURGICAL CAMERA Woodbine Optical Corp. GCJ Class II 1994-06-10
K935643 SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE Regulatory & Marketing Services, Inc. KNY Class II 1994-06-10
K942053 AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET Aesculap, Inc. GCJ Class II 1994-06-10
K942044 BARD ENDOSCOPIC OVERTUBE C.R. Bard, Inc. FED Class II 1994-06-10
K925102 FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT Abbott Laboratories KNT Class II 1994-06-09
K941385 PRO PULSE SYRINGE IRRIGATION SYSTEM Giesy Consultants, Inc. LJH Class II 1994-06-09
K941390 DISPOSABLE ASPIRATION/IRRIGATION TRUMPET VALVE PROBE Deroyal Industries, Inc. GCJ Class II 1994-06-09
K932861 FLEXIFLO GASTROSTOMY KIT Abbott Laboratories KNT Class II 1994-06-09
K942416 HASSON GRASPERS Linvatec Corp. GCJ Class II 1994-06-08
K932626 CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB Cabot Medical Corp. GCJ Class II 1994-06-08
K933330 AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS Aesculap, Inc. GCJ Class II 1994-06-07
K941136 KNOT SLIDE 8383.55 AND 8383.551 Richard Wolf Medical Instruments Corp. GCJ Class II 1994-06-06
K940269 HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER Hollister, Inc. EXJ Class I 1994-06-02
K940347 TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-06-02
K941305 WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE Wilson-Cook Medical, Inc. FBK Class II 1994-06-02
K932310 KIT PAK INCONTINENT SKIN CARE KIT Kit Pak, Inc. EYQ Class I 1994-06-01
K940967 MODIFIED ENDOPATH ILS Ethicon Endo-Surgery, Inc. OCW Class II 1994-05-27
K936038 SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) Surgical Laser Technologies, Inc. FJL Class II 1994-05-27
K942141 EIDOLON ENDOSCOPE COUPLER Eidolon Corp. FET Class II 1994-05-27
K913515 TOTAL CONTAINMENT DEVICE Denco KPF Class II 1994-05-26
K942201 LAPAROSCOPY DILATION SYSTEM Richard Wolf Medical Instruments Corp. GCJ Class II 1994-05-25
K934419 URETERAL CATHETER AND ACCESSORIES Urological Associates of Central Jersey P.A. EYK Class I 1994-05-25
K942202 SUCTION AND IRRIGATION TUBES Richard Wolf Medical Instruments Corp. GCJ Class II 1994-05-25
K941660 GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT Gm Engineering, Inc. KYH Class II 1994-05-24
K941952 SURGITEK INFUSER Surgitek FAD Class II 1994-05-24
K940965 ELIMINATOR BALLOON DILATOR C.R. Bard, Inc. FGE Class II 1994-05-20
K941286 SUTURE MANIPULATOR Richard Wolf Medical Instruments Corp. GCJ Class II 1994-05-20
K940141 LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH Micro-Medical Devices, Inc. GCJ Class II 1994-05-19
K935786 CORSON AND NEZHAT SUCTION/IRRIGATION PROBES Cabot Medical Corp. GCJ Class II 1994-05-19
K934531 AUTO SUTURE DISPOSABLE LIGHT CABLE United States Surgical, A Division of Tyco Healthc FCW Class II 1994-05-18
K940011 MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM Phx Technologies Corp. GCJ Class II 1994-05-18
K934080 URINARY DRAINAGE BAG Kit Pak, Inc. EYT Class I 1994-05-18
K935826 LAPAROSCOPIC/SUCTION/IRRIGATION PROBE Core Dynamics, Inc. GCJ Class II 1994-05-18
K941648 BLUE PLANET LENS FOG REDUCTION & CLEANING KIT Blue Planet Industries, Inc. FEB Class II 1994-05-17
K936102 DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES Davol Inc., Sub. C. R. Bard, Inc. GCJ Class II 1994-05-17
K934142 URINARY DRAINAGE BAG Key Medical Services, Inc. EXR Class II 1994-05-17
K930667 REUSABLE LAPAROSCOPIC INSTRUMENTS Snowden-Pencer GCJ Class II 1994-05-16
K941541 HSV LAPAROSCOPY SET Henke Sass Wolf of America, Inc. GCJ Class II 1994-05-16
K941672 URI-CATH CATHETER Gesco Intl., Inc. GBM Class II 1994-05-16
K934697 MICROVASIVE MAXFORCE Boston Scientific Corp KNQ Class II 1994-05-16
K941967 HSW LAPAROSCOPE AND ACCESSORIES Henke-Sass, Wolf GmbH GCJ Class II 1994-05-16
K940911 BASICS ENDOSCOPY SYSTEM Cox Medical Ent., Inc. KGE Class II 1994-05-16
K941134 EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT H & C Chemical, Inc. FEB Class II 1994-05-16
K936279 GALILEO ENDOSCOPES Galileo Electro-Optics Corp. GCJ Class II 1994-05-16
K936248 MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS Medicon Instruments, Inc. GCJ Class II 1994-05-16
K935915 WET SENSE Edson Corp. KPN Class II 1994-05-13
K933497 LAPAROSCOPIC COVERED SURGICAL RETRACTOR Advanced Surgical, Inc. GCJ Class II 1994-05-12
K935986 GORE LAPAROSCOPIC SUTURE PASSER W. L. Gore & Associates, Inc. GCJ Class II 1994-05-12
K932553 DISPOSABLE SUTURE PLACEMENT SYSTEM Laurus Medical Corp. GCJ Class II 1994-05-12
K940346 SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-05-12
K936250 RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP Medicon Instruments, Inc. GCJ Class II 1994-05-12
K941105 UORCAP,MODEL NUMBER UDS-UCAP Laborie Medical Tech, Inc. EXY Class II 1994-05-10
K940780 SCOPEJOCKEY Fibertech Instruments, Inc. OCU Class II 1994-05-10
K921680 E-Z PEG Mill-Rose Laboratory KNT Class II 1994-05-06
K941250 TROCAR AND CANNULA Debusk Technology Corp. GCJ Class II 1994-05-06
K934916 CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS Conmedcorp GCJ Class II 1994-05-05
K933458 SURGICAL TROCARS Ximed Medical Systems GCJ Class II 1994-05-05
K940875 ADJUSTABLE BALLOON DISSECTION CANNULA Origin Medsystems, Inc. GCJ Class II 1994-05-03
K925854 VYGON - ENTERAL FEEDING TUBE - POLYURETHANE Vygon Corp. KNT Class II 1994-05-02
K921370 MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION Medical Innovations Corp. KNT Class II 1994-05-02
K935754 MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER Cook Urological, Inc. GCJ Class II 1994-05-02
K921652 MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT Medical Innovations Corp. KNT Class II 1994-05-02
K940019 GABRIEL URETERAL ILLUMINATOR SYSTEM Gabriel Medical, Inc. FCS Class II 1994-05-02
K940551 ENDOSCOPIC SURGICAL INSTRUMENTS Tnco, Inc. GCJ Class II 1994-04-29
K941276 BRIMFIELD PRECISION SECOND GENERATION GRASPER/DISSECTOR Springfield Surgical Instruments GCJ Class II 1994-04-29
K940431 TECNADYNE 20/20 FOG INHIBITOR KIT Tecnadyne Scientific, Inc. GCJ Class II 1994-04-29
K931113 CADD-TPN(TM) AMBULATORY INFUSION SYSTEM Pharmacia Deltec, Inc. FIH Class II 1994-04-28
K935461 VECTOR AMBULATORY DRUG DELIVERY SYSTEM Infusion Technology Intl. FIH Class II 1994-04-28
K934371 BIP MULTI MODIFICATION Bip USA, Inc. KNW Class II 1994-04-28
K924792 MULTIPLE PURPOSE FORCEPS Nusurg, Inc. GCJ Class II 1994-04-28
K940891 TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER Tecnadyne Scientific, Inc. GCJ Class II 1994-04-26
K930887 BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) Birtcher Medical Systems, Inc. GCJ Class II 1994-04-25
K936114 BIRTCHER PERICARDIAL KNIVES Birtcher Medical Systems, Inc. GCJ Class II 1994-04-25
K940157 ENLINE MONOPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS Surgigus Instruments, Inc. GCJ Class II 1994-04-25
K940428 INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR Innerdyne Medical, Inc. GCJ Class II 1994-04-25
K935071 INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-04-25
K932987 BIRTCHER LAPAROSCOPE AND ACCESSORIES Birtcher Medical Systems, Inc. GCJ Class II 1994-04-25
K941316 BRIMFIELD PRECISION FAN RETRACTOR Springfield Surgical Instruments GCJ Class II 1994-04-22
K934559 KARL STORZ XENON LIGHT SOURCE MODEL 201320-20 KARL STORZ Endoscopy-America, Inc. GCT Class II 1994-04-22
K934069 MILLEX, DUALEX (PLUS, ULTRA) Millipore Corp. FIB Class II 1994-04-21
K935756 ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT Ethicon Endo-Surgery, Inc. OCW Class II 1994-04-21
K935207 ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 Specialty Medical Systems, Inc. GCJ Class II 1994-04-21
K940900 APPENDIX EXTRACTOR 8385.50 Richard Wolf Medical Instruments Corp. GCJ Class II 1994-04-20
K940270 LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM Welch Allyn, Inc. GCT Class II 1994-04-20
K921456 FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM Fresenius USA, Inc. FKP Class II 1994-04-20
K934266 COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER Sierra Laboratories, Inc. EXJ Class I 1994-04-19
K941500 TISSUE ISOLATION AND RETRIEVAL BAG Advanced Surgical, Inc. GCJ Class II 1994-04-19
K941549 BIOPSY NEEDLE AND HOUSING Biopsys Medical, Inc. KNW Class II 1994-04-19
K933169 INMAN ENDOSCOPIC BLUNT DISSECTOR Inman Medical Corp. GCJ Class II 1994-04-19

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