meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
1998-07-01

Clearances · page 56 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K981598 HERNIA MESH STABILIZER Medivices Co. GCJ Class II 1998-07-01
K981320 DAUM BONE BIOPSY SET Daum Corp. KNW Class II 1998-06-29
K963440 DIALOG DIALYSIS MACHINE B. Braun Medical AG KDI Class II 1998-06-26
K964514 CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS Corpak, Inc. FKO Class II 1998-06-26
K980948 VED VALU- VACUUM ERECTION DEVICE Mission Pharmacal Comp LKY Class II 1998-06-25
K981506 RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) Repro-Med Systems, Inc. LKY Class II 1998-06-25
K973251 KSEA CALCUSON KARL STORZ Endoscopy-America, Inc. FEO Class II 1998-06-22
K981166 ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 Inrad KNW Class II 1998-06-22
K981286 SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS Armm, Inc. KDH Class II 1998-06-19
K981003 ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES International Medical Products, Inc. KPO Class II 1998-06-16
K981233 KSEA CALCUSPLIT KARL STORZ Endoscopy-America, Inc. FFK Class II 1998-06-15
K980980 MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 Konigsberg Instruments, Inc. FFX Class II 1998-06-15
K973096 NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM Neotonus, Inc. KPI Class II 1998-06-12
K980659 DRYALYSATE CONCENTRATE Advanced Renal Technologies, Inc. KPO Class II 1998-06-11
K981477 MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE Medical Biopsy, Inc. KNW Class II 1998-06-10
K980870 RUSCH SILICONE FOLEY CATHETER Rusch, Inc. EZL Class II 1998-06-09
K980653 PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM Cordis Corp. FGE Class II 1998-06-09
K980946 MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP Dentsleeve Pty., Ltd. FFX Class II 1998-06-08
K981667 HYDROPHILIC COATED GUIDEWIRE Lake Region Mfg., Inc. KNY Class II 1998-06-05
K981203 RUSCH BLAKEMORE 3 LUMEN, STERILE Rusch Intl. KNT Class II 1998-06-05
K981669 SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR Boston Scientific Corp FHN Class II 1998-06-04
K981491 UROSURGE FILASTENT URETERAL STENT Urosurge, Inc. FAD Class II 1998-05-29
K974771 STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL Stryker Endoscopy GCJ Class II 1998-05-29
K981700 VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM Origin Medsystems, Inc. GCJ Class II 1998-05-29
K981489 UROSURGE SPIRASTENT PLUS URETERAL STENT Urosurge, Inc. FAD Class II 1998-05-29
K980917 ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR Fortune Medical Instrument Corp. GCA Class II 1998-05-27
K981043 DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL Solution Technologies KPO Class II 1998-05-26
K980401 FLEXIBLE FIBERSCOPES AND ACCESSORIES Richard Wolf Medical Instruments Corp. FAJ Class II 1998-05-21
K980676 SPIGAL NEEDLE Gallini U.S., LLC KNW Class II 1998-05-21
K980636 FIBER OPTIC ENDOILLUMINATION PROBE Dutch Ophthalmic USA, Inc. FFS Class II 1998-05-20
K980604 SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES Smith & Nephew, Inc. GCJ Class II 1998-05-19
K980658 PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 Baxter Healthcare Corp FJI Class II 1998-05-19
K980797 PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR Peregrine Surgical , Ltd. MPA Class II 1998-05-19
K980656 PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 Baxter Healthcare Corp KDI Class II 1998-05-19
K981085 GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM Gambro Healthcare FIP Class II 1998-05-18
K973892 RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) Rusch Intl. KNT Class II 1998-05-18
K974584 FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS Fresenius USA, Inc. KDI Class II 1998-05-14
K980530 PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 Peregrine Surgical , Ltd. MPA Class II 1998-05-12
K981256 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE Ximed/Prosure/Injectx FAS Class II 1998-05-12
K974196 MEGAVAC SYSTEM Barry J. Kaplan, Inc. LKY Class II 1998-05-12
K973820 USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE Circon Corp. FAS Class II 1998-05-12
K980859 HEMOCOR HPH MINI HEMOCONCENTRATOR Minntech Corp. KDI Class II 1998-05-12
K980808 ENDO FMS UROLOGY Future Medical Systems, Inc. LJH Class II 1998-05-08
K980567 CHARGER (ED) Walling Medical Equipment Co. LKY Class II 1998-05-06
K980752 XTEND Walling Medical Equipment Co. LKY Class II 1998-05-06
K980479 QUICK-CUT AUTOMATIC BIOPSY SYSTEM Gallini U.S., LLC KNW Class II 1998-05-06
K980815 ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER Ethicon Endo-Surgery, Inc. OCW Class II 1998-05-01
K980623 N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE N-Tech Endoscopy, Inc. GCJ Class II 1998-04-30
K980592 NTECH CYSTOSCOPES N-Tech Endoscopy, Inc. FAJ Class II 1998-04-28
K980350 VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 Cuda Products Co. GCJ Class II 1998-04-28
K980372 MANAN VS ACCESS NEEDLE/SET Medical Device Technologies, Inc. FGE Class II 1998-04-27
K980279 SONY DXC-LS1 COLOR VIDEO CAMERA Sony Medical Electronics Co. GCJ Class II 1998-04-24
K981258 MANAN MALECOT BASKET DRAINAGE CATHETER Medical Device Technologies, Inc. FEW Class II 1998-04-22
K981229 MANAN MANTA CATHETER FIXATION DISK Medical Device Technologies, Inc. KNY Class II 1998-04-22
K980795 UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp EZN Class II 1998-04-22
K974382 ACKERMANN SURGICAL INSTRUMENTS Ackermann Instrumente GmbH GCJ Class II 1998-04-21
K980465 OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS Olympus America, Inc. FDT Class II 1998-04-21
K980305 AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE Applied Medical Technology, Inc. KNT Class II 1998-04-16
K980164 STERICHEK PERACETIC ACID REAGENT STRIPS Environmental Test Systems, Inc. MSY Class II 1998-04-16
K980599 NTECH ARTHROSCOPE N-Tech Endoscopy, Inc. GCJ Class II 1998-04-15
K980145 AMT DECOMPRESSION TUBES Applied Medical Technology, Inc. KGC Class II 1998-04-10
K980079 COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES Lumenis, Inc. GCJ Class II 1998-04-09
K980804 SABRE BT BLUNT0TIP SURGICAL TROCAR Endoscopic Concepts, Inc. FBQ Class II 1998-04-01
K974600 UROMED PATCH Uromed Corp. MNG Class I 1998-03-31
K980027 PEREGRINE SHIELDED DIFFUSION PROBE Peregrine Surgical , Ltd. MPA Class II 1998-03-31
K973698 SCION BALLOON ELEVATOR Scion International, Inc. GCJ Class II 1998-03-31
K974493 FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES Fiegert-Endotech Medizintechnik GmbH FDS Class II 1998-03-31
K980919 ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER Fortune Medical Instrument Corp. EZL Class II 1998-03-31
K980025 PEREGRINE TAPERED DIFFUSION PROBE Peregrine Surgical , Ltd. MPA Class II 1998-03-31
K974902 JMS APHERESIS NEEDLE Jms Co., Ltd. FIE Class II 1998-03-30
K974806 VYGON NEO-SUMP Vygon Corp. KNT Class II 1998-03-23
K974788 CRE(TM) BALLOON DILATATION CATHETER Boston Scientific Corp KNQ Class II 1998-03-20
K974798 STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS Environmental Test Systems, Inc. LIF Class II 1998-03-20
K963794 PUNCTURENEEDLE Ferguson Medical KNW Class II 1998-03-19
K980023 ENDOPATH AND PROXIMATE LINEAR CUTTERS Ethicon Endo-Surgery, Inc. GCJ Class II 1998-03-18
K973129 DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS Denver Biomaterials, Inc. KPM Class II 1998-03-17
K973364 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG Maersk Medical A/S KNX Class II 1998-03-17
K974796 LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER Medispec, Ltd. FFK Class II 1998-03-12
K980291 IMPOWER EXTERNAL VACUUM SYSTEM Imagyn Medical Technologies, Inc. LKY Class II 1998-03-11
K970662 CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) Baxter Healthcare Corp MSF Class II 1998-03-11
K970653 CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) Baxter Healthcare Corp MSF Class II 1998-03-11
K980022 ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) Ethicon Endo-Surgery, Inc. GCJ Class II 1998-03-09
K974631 DAUM NEUROBIOPSY NEEDLE Daum Corp. KNW Class II 1998-03-09
K980123 CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET Louisville Laboratories, Inc. GCJ Class II 1998-03-09
K974574 DAUM NEUROPUNCTURE NEEDLE Daum Corp. KNW Class II 1998-03-06
K974575 DAUM ASPIRATIONBIOPSY NEEDLE Daum Corp. KNW Class II 1998-03-06
K974576 DAUM BIOPSYGUN Daum Corp. KNW Class II 1998-03-06
K980281 WELCH ALLYN XENON 300 LIGHT SOURCE Welch Allyn, Inc. GCT Class II 1998-02-27
K974570 PERITONEAL DIALYSIS CATHETER CONNECTOR Medigroup, Inc. FKO Class II 1998-02-27
K973409 KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS Davis & Geck, Inc. KNT Class II 1998-02-27
K971710 ULTRACON ULTRAFILTRATOR Quantic Biomedical, Inc. FJI Class II 1998-02-27
K973909 KSEA ENDOTIP SYSTEM KARL STORZ Endoscopy-America, Inc. GCJ Class II 1998-02-27
K980050 MENTOR SKIN PROTECTION PAD Mentor Corp. GCJ Class II 1998-02-27
K974082 THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE Performance Plus, Inc. LKY Class II 1998-02-27
K973120 READYCATH CATHETER Medical Technologies of Georgia GBM Class II 1998-02-25
K974173 ERECAID SYSTEM/STAY EREC SYSTEM Imagyn Medical Technologies, Inc. LKY Class II 1998-02-25
K973700 HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. GCJ Class II 1998-02-24
K971925 MEDCOMP BIO-FLEX CS CATHETER (CS100) Medical Components, Inc. MSD Class II 1998-02-23
K972207 MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM Medcomp MSD Class II 1998-02-23
K974775 SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE Airtronic Services, Inc. FAP Class II 1998-02-19

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