meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
54
Latest Decision
1996-12-10

Clearances · page 61 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962915 ACTIS (VENOUS FLOW CONTROLLER) Vivus, Inc. LKY Class II 1996-12-10
K964334 EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) Shippert Medical Technologies Corp. GCJ Class II 1996-12-09
K961607 VIRAPUMP II (MODELS AND MODEL M) Viatro, Corp. FEB Class II 1996-12-06
K962969 MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA Medical Device Technologies, Inc. KNW Class II 1996-12-06
K963328 AMS AMBICOR PENILE PROSTHESIS American Medical Systems, Inc. FAE Class II 1996-12-04
K962172 FLEXIBLE MINI-FIBERSCOPES Richard Wolf Medical Instruments Corp. FBN Class II 1996-12-02
K963517 SPECTRA SCIENCE BIOPSY FORCEPS Spectrascience, Inc. FCL Class I 1996-12-02
K963999 AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE United States Surgical, A Division of Tyco Healthc OCW Class II 1996-11-27
K962570 ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE Gallini Intl., Inc. FCG Class II 1996-11-27
K962569 BIOMID BONE MARROW BIOPSY NEEDLE Gallini Intl., Inc. FCG Class II 1996-11-27
K962568 ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES Gallini Intl., Inc. FCG Class II 1996-11-25
K963397 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER Boston Scientific Corp FGE Class II 1996-11-25
K963750 RETRIEVAL SNARE Boston Scientific Corp FGO Class II 1996-11-22
K963344 DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE Vision-Sciences, Inc. FAM Class II 1996-11-21
K963323 ENDO VIP Richard Wolf Medical Instruments Corp. GCJ Class II 1996-11-21
K961407 SPEED-CUT Gallini Intl., Inc. KNW Class II 1996-11-21
K963484 BARD HIGH FLOW PAPILLOTOME Bard Interventional Products Div. KNS Class II 1996-11-19
K961906 UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 Spectrum Medsystems Corp. EYZ Class I 1996-11-19
K955110 NAVARRE PERCUTANEOUS BILIARY DRAINAGE Navarre Biomedical , Ltd. FGE Class II 1996-11-07
K963815 REUSABLE TROCAR WITH SLEEVE (COMMON) Pilling Weck Group GCJ Class II 1996-11-05
K961895 FLEXILOG LS 13921 Oakfield Instruments, Ltd. KLA Class II 1996-11-04
K963046 ENDOCAM Corin USA GCJ Class II 1996-11-01
K962083 KARL STORZ REMORGIDA FORCEPS KARL STORZ Endoscopy-America, Inc. KNS Class II 1996-11-01
K962081 COMBILINES HEMODIALYSIS BLOOD TUBING SET National Medical Care, Medical Products Div., Inc. FJK Class II 1996-11-01
K961361 ASTA-CATH A+ Products GBM Class II 1996-10-31
K962178 BARD TIGER GUIDEWIRE MODEL 000540 C.R. Bard, Inc. OCY Class II 1996-10-29
K963329 ETHICON ENDOSUTURE SYSTEM ETHICON, Inc. GCJ Class II 1996-10-25
K963265 PROSYS SAMEC LA Convatec, A Division of E.R. Squibb & Sons EXJ Class I 1996-10-25
K962925 OLYMPUS B-5/B-7 SERIESBALLOON CATHETER Olympus America, Inc. FGE Class II 1996-10-25
K963222 MICROGYN PLUS STIMULATION DEVICE Hollister, Inc. KPI Class II 1996-10-23
K963227 WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 Products For Medicine GCT Class II 1996-10-23
K962907 SKINNY,FRANSEEN,WESCOTT NEEDLES Baxter Healthcare Corp KNW Class II 1996-10-23
K962611 BARD EAGLE INFLATION DEVICE Ryder Intl. Corp. KOE Class II 1996-10-21
K955299 DPS 4 DIALYZER PREPARATION SYSTEM Seratronics, Inc. LIF Class II 1996-10-21
K961904 AQ HYDROPHILIC DILATORS Cook Urological, Inc. KOE Class II 1996-10-18
K962684 S-357 VIDEO IMAGING SYSTEM Del Medical Systems Corp. GCJ Class II 1996-10-15
K962799 MINIATURE LAPAROSCOPE SET (MINI LAP) Richard Wolf GmbH GCJ Class II 1996-10-11
K962905 TX BIOPSY NEEDLE Gallini S.R.L. FCG Class II 1996-10-11
K963390 BIOPSY INTRODUCER NEEDLE Baxter Healthcare Corp KNW Class II 1996-10-10
K963056 ED-3410, VIDEO DUODENOSCOPE Pentax Precision Instrument Corp. FDT Class II 1996-10-10
K961841 BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) C.R. Bard, Inc. FAS Class II 1996-10-09
K962921 BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER C.R. Bard, Inc. EZN Class II 1996-10-09
K962707 MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET Minntech Corp. KDI Class II 1996-10-09
K961463 HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 Heartport, Inc. GCJ Class II 1996-10-08
K962897 EG-3400, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. FDS Class II 1996-10-04
K962676 DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE United States Endoscopy Group, Inc. FGO Class II 1996-10-04
K961664 COMPAT NASOJEJUNAL FEEDING TUBE Sandoz Nutrition KNT Class II 1996-10-04
K962652 URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) Customed, Inc. KNX Class II 1996-10-04
K953983 EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE Richard Wolf Medical Instruments Corp. FAS Class II 1996-10-02
K963113 FLEXIFLO POLYG GASTOSTOMY TUBE Abbott Laboratories KNT Class II 1996-10-02
K962651 S-52 ELECTRONIC VIDEO LAPAROSCOPE Del Medical Systems Corp. GCJ Class II 1996-09-30
K960301 ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR Del Medical Systems Corp. GCJ Class II 1996-09-30
K953823 ARTERIAL VENOUS BLOOD TUBING SET Medisystems Corp. FJK Class II 1996-09-23
K962427 COBE CENTRYSYSTEM 700 HG HEMODIALYZER Gambro Healthcare KDI Class II 1996-09-20
K963044 ENDOBEAM Corin USA GCT Class II 1996-09-20
K963043 ENDOSPOT Corin USA FCW Class II 1996-09-20
K961536 FLEXSCOPE Matrix Medica, Inc. GDB Class II 1996-09-18
K962393 KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION KARL STORZ Endoscopy-America, Inc. GCM Class II 1996-09-17
K952660 BRAUN HEMODIALYSIS CATHETER B.Braun Medical, Inc. MPB Class II 1996-09-17
K961345 DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE Applied Medical Technologies KNT Class II 1996-09-17
K962506 [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] Gynecare Innovation Center FJL Class II 1996-09-16
K960503 DANTEC DUET Dantec Medical, Inc. FEN Class II 1996-09-16
K961048 OLYMPUS MH-246R BALLOON SHEATH Olympus America, Inc. ODG Class II 1996-09-16
K962460 EG-3800T, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. FDS Class II 1996-09-16
K962900 SELF RETAINING MALE EXTERNAL URINARY CATHETER Hollister, Inc. EXJ Class I 1996-09-16
K955002 MAHURKAR 8 FR DUAL LEMEN CATHETER Quinton, Inc. MPB Class II 1996-09-13
K961039 BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL Dayspring Medical, Inc. FJI Class II 1996-09-12
K962493 ENDOSCOPIC CLIP APPLIER Aesculap, Inc. OCW Class II 1996-09-11
K961800 HEAD MOUNTED DISPLAY Vista Medical Technologies, Inc. GCJ Class II 1996-09-11
K962104 AIRLIFT BALLOON RETRACTON SYSTEM Origin Medsystems, Inc. GCJ Class II 1996-09-11
K962595 KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS KARL STORZ Endoscopy-America, Inc. FFS Class II 1996-09-04
K962375 MICROVASIVE BALLOON GASTROSTOMY TUBE KIT Boston Scientific Corp KNT Class II 1996-09-04
K962020 S-41 & S-41S VIDEO IMAGING SYSTEM Del Medical Systems Corp. GCJ Class II 1996-08-30
K961697 OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE Medical Device Intl., Inc. EZL Class II 1996-08-30
K962259 LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) Tiller Mind Body, Inc. KPL Class II 1996-08-29
K961702 KSEA VAPORIZATION ELECTRODES Karl Storz Endoskop GmbH FAS Class II 1996-08-29
K935512 CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE Corpak Co. KNT Class II 1996-08-29
K954623 REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) Gambro Healthcare FKT Class II 1996-08-28
K962193 PORTLAND TROCARS Surgical Innovations Plc GCJ Class II 1996-08-28
K962472 RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER Rusch Intl. FAP Class II 1996-08-27
K960903 KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY KARL STORZ Endoscopy-America, Inc. GCJ Class II 1996-08-22
K961416 DIALYSIS MIXING & HOLDING TANK Dial Medical Supply FIN Class II 1996-08-21
K960474 COBE CENTRYSYSTEM 600 HG HEMODIALYZERS Cobe Renal Care, Inc. KDI Class II 1996-08-14
K962670 NHMC IRRIGATION TRAY National Healthcare Mfg. Corp. LJH Class II 1996-08-14
K962005 EXTRAHAND BALLOON RETRACTOR Origin Medsystems, Inc. GCJ Class II 1996-08-12
K961872 INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER Hollister, Inc. KPI Class II 1996-08-09
K962346 PAPILLOTOME United States Endoscopy Group, Inc. KNS Class II 1996-08-08
K954987 ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl KDI Class II 1996-08-08
K961825 ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 Baxter Healthcare Corp KDJ Class II 1996-08-06
K960574 ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM Sherwood Medical Co. FHO Class II 1996-08-05
K961884 CATH CADDIE Mark-Clark KNT Class II 1996-08-01
K962770 UROSURGE ACUTRAINER Princeton Regulatory Assoc. KPN Class II 1996-08-01
K960230 SNARE Lighthouse Medical, Inc. FDI Class II 1996-07-31
K962387 OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) Olympus America, Inc. FFL Class II 1996-07-31
K961438 BALLON DILATATION CATHETER Boston Scientific Corp KNQ Class II 1996-07-31
K955762 PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM Fresenius USA, Inc. KPF Class II 1996-07-31
K960231 SPHINCTEROTOME Lighthouse Medical, Inc. KNS Class II 1996-07-31
K962077 BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER C.R. Bard, Inc. KNW Class II 1996-07-30
K961693 DALE GASTROSTOMY TUBE HOLDER Dale Medical Products, Inc. PLI Class II 1996-07-30
K962254 NHMC URETHRAL CATHETERIZATION TRAY National Healthcare Mfg. Corp. FCM Class II 1996-07-29

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