meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
41
Latest Decision
1994-04-18

Clearances · page 72 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K941012 LOW PRESSURE TAMPONADE BALLOON CATHETER Applied Medical Resources EYB Class II 1994-04-18
K936041 UROGRAM CYSTOMETROGRAM Myo/Kinetic Systems, Inc. FEN Class II 1994-04-18
K940542 NAMIC ARIA(TM) INFLATION DEVICE American Medical Systems, Inc. EZN Class II 1994-04-18
K941010 ACUCISE GUIDEWIRE EXCHANGE SHEATH Applied Medical Resources EYB Class II 1994-04-18
K940232 INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P. Innerdyne Medical, Inc. GCJ Class II 1994-04-18
K931755 RIWOLITH 2280 PROBES Richard Wolf Medical Instruments Corp. FFK Class II 1994-04-15
K930344 SILICONE FOLEY CATHETER Cook Urological, Inc. EZL Class II 1994-04-15
K922527 BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY C.R. Bard, Inc. KOD Class II 1994-04-14
K941024 AESCULAP TROCAR COLLAR Aesculap, Inc. GCJ Class II 1994-04-13
K940241 ACUFEX VIDEO SYSTEM Acufex Microsurgical, Inc. GCJ Class II 1994-04-12
K931778 LAPAROSCOPY INSTRUMENTS Buckman Co., Inc. GCJ Class II 1994-04-12
K930965 LOS 3D VISION 100 Laser Optik Systeme GmbH & Co. KG GCJ Class II 1994-04-11
K941092 MURDOCH LAPAROSCOPE LENS CLEANER Cook, Inc. GCJ Class II 1994-04-11
K935774 CURITY FAST-CATH FEMALE CATHETER KIT Kendall Healthcare Products Co. Div.Of Tyco Health EYT Class I 1994-04-11
K940962 LIQUID LIGHT 500 Incredivision, Inc. FFS Class II 1994-04-08
K933537 ENCOMPAS COMFORT BLOCK # 0B-10 Encompas Unlimited, Inc. MNK Class I 1994-04-08
K940963 XENON LIGHT SOURCE Incredivision, Inc. FFS Class II 1994-04-08
K932128 CMI E-Z FLO BULB P.N. 701 Columbia Medical & Surgical, Inc. FFY Class I 1994-04-07
K940398 AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II United States Surgical, A Division of Tyco Healthc GCJ Class II 1994-04-07
K931850 VERRSS PNEUMO NEEDLE Advanced Surgical, Inc. GCJ Class II 1994-04-07
K936198 ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES Carl Zeiss, Inc. GCT Class II 1994-04-06
K925818 AKCESS-CATH Akcess Medical Products, Inc. LFJ Class II 1994-04-05
K932306 MICROINFUSOR Sandhill Scientific, Inc. FFX Class II 1994-04-01
K931175 SCHUSTER DISPOSABLE BALLOON PROBE Sandhill Scientific, Inc. FAP Class II 1994-04-01
K933175 GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE Greenwald Surgical Co., Inc. FAS Class II 1994-04-01
K933173 GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE Greenwald Surgical Co., Inc. FAS Class II 1994-04-01
K933174 GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE Greenwald Surgical Co., Inc. FAS Class II 1994-04-01
K930813 PISTOL SUCTION/IRRIGATION PROBE Origin Medsystems, Inc. GCJ Class II 1994-03-31
K936097 VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL Micromedical Devices, Inc. GCJ Class II 1994-03-31
K933941 MENLO CARE URINARY DIVERSION STENT Menlo Care, Inc. FAD Class II 1994-03-31
K940155 ENLINE ENDOSCOPIC SURGICAL INSTRUMENTS Surgigus Instruments, Inc. GCJ Class II 1994-03-30
K940199 DISSECTOR Automated Medical Products Corp. GCJ Class II 1994-03-30
K940203 TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS Life-Tech Intl., Inc. FEN Class II 1994-03-30
K935548 CATHEJELL S STERILE LUBRICATING JELLY Pharmazeutische Fabrik Montavit GmbH FHX Class II 1994-03-30
K932060 MARTIN COLD LIGHT FOUNTAIN Medline GCJ Class II 1994-03-30
K922005 GRANULYTE DIALYSATE CONCENTRATE Fresenius USA, Inc. KPO Class II 1994-03-30
K925654 CD HOME DIALYSERVICE HEMODIALYSIS TRAY Cd Medical, Inc. KOC Class II 1994-03-30
K940587 FLEX-I-PORT Access Surgical Intl., Inc. GCJ Class II 1994-03-29
K934256 GLOBAL MEDICAL CUTTING BIOPSY NEEDLE Global Medical Prods, Inc. FCG Class II 1994-03-28
K940439 GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT Conmedcorp GCJ Class II 1994-03-28
K921818 ABBOTT SMART CAP Abbott Laboratories KDJ Class II 1994-03-28
K933109 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS Boston Pacific Medical, Inc. KOD Class II 1994-03-28
K936168 WILSON-COOK BALLOON INFLATION DEVICE Wilson-Cook Medical, Inc. KNT Class II 1994-03-28
K923843 FOGLESS Sorex Medical OCT Class II 1994-03-25
K922402 4 SURE TM ENTERAL FEEDING BAG Boston Pacific Medical, Inc. FPD Class II 1994-03-25
K913468 ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY Cook, Inc. LFJ Class II 1994-03-24
K931879 REFLEX HTR Richard-Allan Medical Ind., Inc. GCJ Class II 1994-03-24
K925958 SCISSOR FOR LAPAROSCOPIC SURGERY GU USE Zinnanti Surgical Instruments, Inc. GCJ Class II 1994-03-24
K930254 DAVIS+GECK REUSABLE TRTOCARS Davis & Geck, Inc. GCJ Class II 1994-03-24
K935604 LASERSONICS TISSUE MORCELLATOR SET Heraeus Surgical, Inc. GCJ Class II 1994-03-23
K934937 KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-03-23
K940601 GAMBRO BICART 720G C.G.H. Medical, Inc. KPO Class II 1994-03-22
K936194 COAXIAL BIOPSY NEEDLE Bard Gynecology and Radiology FCG Class II 1994-03-22
K935109 SDR (SOFT DISSECTOR RAKE) Phx Technologies Corp. GCJ Class II 1994-03-21
K923497 FLUSHING IRRIGATION SET Orion Life Systems, Inc. KDH Class II 1994-03-21
K940688 TROCAR TUBE Phx Technologies Corp. GCJ Class II 1994-03-18
K934155 WATTS RAKE WITH LEUR PORT & AQUA-PROBE TIP Phx Technologies Corp. GCJ Class II 1994-03-18
K935234 STRYKER ENDOSCOPIC VIDEO ACCESSORIES Stryker Endoscopy GCJ Class II 1994-03-18
K934153 WATTS RAKE WITH LEUR LOCK PORT Phx Technologies Corp. GCJ Class II 1994-03-18
K932809 FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR Excalibur Engineering Care of Rms, Inc. EZL Class II 1994-03-17
K933776 OPTIK LAPAROSCOPE Optik GCJ Class II 1994-03-16
K940687 TROCAR Phx Technologies Corp. GCJ Class II 1994-03-16
K934738 AUTOSUTURE ENDOSCOPIC SUTURING DEVICE United States Surgical, A Division of Tyco Healthc OCW Class II 1994-03-16
K932266 SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN Symbiosis Corp. KGE Class II 1994-03-15
K924436 BARD UROTRACK II MONITORING C.R. Bard, Inc. KOC Class II 1994-03-15
K935814 MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE Boston Scientific Corp KNW Class II 1994-03-14
K935442 MAHE INSTRUMENTS Mahe-Medizintechnik GCJ Class II 1994-03-14
K935115 EEC PROBE Phx Technologies Corp. GCJ Class II 1994-03-11
K915801 BIP-COAX-SYSTEM Uni-Quatro Industries Canada, Inc. FCG Class II 1994-03-11
K934737 LASSO (SCHWAITZBERG) SUTURE SNARE Performance Surgical Instruments Corp. GCJ Class II 1994-03-09
K934174 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ETHICON, Inc. OCW Class II 1994-03-09
K914524 FLUID PUMP, CP #3 United States Endoscopy Group, Inc. FEB Class II 1994-03-09
K933618 EAGLE MEDICAL ANTI-FOG KIT Eagle Medical Intl. OCT Class II 1994-03-07
K935834 TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE Technology Marketing Group FBN Class II 1994-03-07
K935645 FLOWGUN REUSABLE IRRIGATION PROBES O.R. Concepts, Inc. GCJ Class II 1994-03-07
K932397 RELIANT Allan Walling Medical Equipment Co. LKY Class II 1994-03-07
K934370 BIP BIOPSY NEEDLE MODIFICATION Bip USA, Inc. FCG Class II 1994-03-07
K935557 URINARY DRAINAGE BAG Puritas Health Care, Inc. KNX Class II 1994-03-07
K932617 S*E*M*M-SET & C*U*R*T-SET Market-Tiers, Inc. GCJ Class II 1994-03-07
K933135 DAWN DISPOSABLE BIOPSY FORCEPS Dawn Medical FCL Class I 1994-03-07
K923065 BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL Baxter Healthcare Corp FKX Class II 1994-03-04
K932696 ISI(R) CURVED, TAPERED DISSECTING FORCEPS Innovative Surgical, Inc. GCJ Class II 1994-03-03
K932695 ISI(R) PORPOISE NOSE DISSECTING FORCEPS Innovative Surgical, Inc. GCJ Class II 1994-03-03
K932465 LI VASECTOMY Femcare , Ltd. KOA Class I 1994-03-02
K930848 SENSING TIP SURGICAL TROCAR Origin Medsystems, Inc. GCJ Class II 1994-03-01
K933449 R AND D BATTERIES, INC. PART NUMBER 5017 R & D Batteries, Inc. FCO Class I 1994-03-01
K934807 PUNCTURE CLOSURE DEVICE Advanced Surgical, Inc. GCJ Class II 1994-03-01
K926479 BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM Davol, Inc. GCJ Class II 1994-03-01
K931957 SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS Symbiosis Corp. FCL Class I 1994-02-28
K934772 GASTRONOMY TUBE HOLDER Nelmed Corp. KNT Class II 1994-02-28
K934315 ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME Endovations KNS Class II 1994-02-28
K934291 SURGICOT FOG FREE Ssa Aquisition Corp. OCT Class II 1994-02-28
K934636 ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR Annex Medical, Inc. FFL Class II 1994-02-25
K933126 COMFORTCARE SYSTEM Patsy J. Trisler, J.D. EYZ Class I 1994-02-25
K933962 GM CONTINUOUS FLOW BIOPSY PROBE Gm Engineering, Inc. FDC Class II 1994-02-25
K934527 FASCIA STITCHER Laparomed Corp. GCJ Class II 1994-02-25
K935472 R & D BATTERIES, INC. PART NUMBER 5047 R & D Batteries, Inc. FCO Class I 1994-02-25
K926080 DMI LAPAROSCOPIC IRRIGATION PUMP Diversified Medical Instruments, Inc. GCJ Class II 1994-02-25
K940365 MANAN ADAPTER FOR BARD BIOPTY SYSTEM Manan Medical Products, Inc. KNW Class II 1994-02-25
K933353 IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES Utah Pioneer Medical, Inc. GCJ Class II 1994-02-22

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