meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
57
Latest Decision
1991-06-11

Clearances · page 82 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K911817 ENDOSCOPIC CLIP APPLIER Surgitech C/O Collier, Shannon, Rill & Scott GCJ Class II 1991-06-11
K912023 LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR Laserscope GCJ Class II 1991-06-11
K911104 PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 Hgm Medical Laser Systems, Inc. FEX Class I 1991-06-11
K910720 BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER C.R. Bard, Inc. FCG Class II 1991-06-10
K910444 BROWNE MEDICAL SYSTEMS IMAGEPRO Browne Medical Systems, Inc. FAP Class II 1991-06-10
K911091 DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES Diagnostic Ultrasound Corp. FAP Class II 1991-06-10
K911488 LAPAROSCOPIC RINSING CONTAINER United States Endoscopy Group, Inc. GCJ Class II 1991-06-06
K911581 PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION Johnson & Johnson Interventional Systems FGE Class II 1991-06-04
K905553 LITHOTRIPTOR SYSTEM MODEL 27080 Karl Storz GmbH & Co. (Kst) FFK Class II 1991-06-04
K911053 CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT Circon Video GCJ Class II 1991-06-03
K912214 BARD SINGULAR BIOPSY FORCEPS C.R. Bard, Inc. FCL Class I 1991-05-30
K910876 AUTOCATH(TM) SET Cook Urological, Inc. GBM Class II 1991-05-28
K911329 BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE C.R. Bard, Inc. FOC Class II 1991-05-28
K910912 MOSS NASAL TUBE MARK IV Moss Medical Products KNT Class II 1991-05-28
K911106 MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG Baxter Healthcare Corp KOC Class II 1991-05-28
K910584 ONE STEP BUTTON(TM) Applied Medical Technologies KGC Class II 1991-05-23
K905779 ALDETECT Pochemco, Inc. FJI Class II 1991-05-23
K911397 HYPODERMIC NEEDLES, SINGLE LUMEN Popper & Sons, Inc. FCG Class II 1991-05-20
K910694 ZINETICS INTERNAL REFERENCE PROBE Zinetics Medical, Inc. FFT Class I 1991-05-17
K910371 URODYNAMIC MEASURING SYSTEM Browne Medical Systems, Inc. FAP Class II 1991-05-15
K910671 MODEL GS-4700 COMMON DUCT STONE REMOVING KIT Solos Endoscopy, Inc. FGE Class II 1991-05-10
K905590 UCEZ - STERILE LENS FOG REDUCTION DEVICE Inman Liebelt Corp. OCT Class II 1991-05-10
K910653 TOUCHLESS II INTERMITTENT CATHETER C.R. Bard, Inc. FCM Class II 1991-05-06
K910911 MOSS P.E.G. TRAY Moss Medical Products KNT Class II 1991-05-03
K910964 HOT BIOPSY FORCEPS Symbiosis Corp. KGE Class II 1991-05-02
K911292 SCHNEIDER WALLSTENT(R) Pfizer Hospital Products Group, Inc. FGE Class II 1991-05-01
K903345 BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE C.R. Bard, Inc. FAD Class II 1991-04-30
K910246 CORE DISPOSABLE SUCTION/IRRIGATION TUBING Core Dynamics, Inc. GCJ Class II 1991-04-29
K911478 LAPAROSCOPIC SNARE POUCH United States Endoscopy Group, Inc. GCJ Class II 1991-04-29
K910641 INTRODUCER NEEDLES Akcess Medical Products, Inc. KOC Class II 1991-04-29
K910501 PERMANENT SILICONE CATHETERS Akcess Medical Products, Inc. LFJ Class II 1991-04-29
K910502 VESSEL DILATORS Akcess Medical Products, Inc. FKA Class II 1991-04-29
K911157 APPLICATOR LOOP SUTURES Northgate Technologies, Inc. GCJ Class II 1991-04-25
K910214 AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS American Medical Corp. FAE Class II 1991-04-25
K905117 ENDOSCOPE AND ACCESSORIES Northgate Technologies, Inc. GCI Class II 1991-04-25
K911486 LAPAROSCOPIC SUCTION/IRRIGATION CANNULA United States Endoscopy Group, Inc. GCJ Class II 1991-04-25
K911258 KENDALL PEDIATRIC URINE METER Kendall Healthcare Products Co. Div.Of Tyco Health EXR Class II 1991-04-25
K911242 KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health KOD Class II 1991-04-25
K911493 LAPAROSCOPIC IRRIGATION PUMP United States Endoscopy Group, Inc. GCJ Class II 1991-04-25
K910656 WILSON-COOK DISPOSABLE BIOPSY FORCEPS Wilson-Cook Medical, Inc. FLC Class II 1991-04-25
K911411 BARD 3000 PLUS URETEROSCOPY SYSTEM C.R. Bard, Inc. FGB Class II 1991-04-25
K911461 SURGITRON Ellman Intl. Mfg., Inc. GCI Class II 1991-04-25
K910319 ACID CONCENTRATE SOLUTIONS Biopharm, Inc. KPO Class II 1991-04-24
K911484 LAPAROSCOPIC SUCTION IRRIGATION TUBING SET United States Endoscopy Group, Inc. GCJ Class II 1991-04-23
K911482 LAPAROSCOPIC SNARE United States Endoscopy Group, Inc. FDI Class II 1991-04-22
K911481 LAPAROSCOPIC CLEANING BRUSH INSTRUMENT United States Endoscopy Group, Inc. FDX Class II 1991-04-22
K910913 MOSS GASTROSTOMY TUBE Moss Medical Products KNT Class II 1991-04-19
K910479 ARGYLE POLYURETHANE SALEM SUMP TUBE Sherwood Medical Co. BSS Class II 1991-04-19
K910855 ENDOPATH VERESS NEEDLE Symbiosis Corp. FHP Class II 1991-04-18
K910270 PREMIXED DIALYSATE FOR HEMODIAFILTRATION Baxter Healthcare Corp KPO Class II 1991-04-18
K911181 INTIMAX(TM) IRRIGATION CATHETER Applied Vascular Devices, Inc. GCA Class II 1991-04-18
K910321 Y ADAPTOR Akcess Medical Products, Inc. KOC Class II 1991-04-16
K911094 INPERSOL CAPD BIOCAP ADMINISTRATION SET Abbott Laboratories KDI Class II 1991-04-16
K911448 MULTIPLE BIOPSY DEVICE-MBX Triton Technology, Inc. FCK Class II 1991-04-16
K910716 MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE Richard Wolf Medical Instruments Corp. FCX Class II 1991-04-16
K905375 ACCENT DG BALLOON URETERAL DILATOR SET Cook Urological, Inc. EZN Class II 1991-04-12
K910732 CANDELA MINI-UB ENDOSCOPE Candela Laser Corp. ODF Class II 1991-04-12
K904946 HAEMODIALYSIS CONCENTRATE Bdh, Inc. KPO Class II 1991-04-09
K905102 BARD(R) SYRINGE ASSIST IRRIGATION C.R. Bard, Inc. OCX Class II 1991-04-09
K910236 RENAFLO HDF 1350 HEMODIAFILTER Minntech Corp. KDI Class II 1991-04-09
K905505 VAS-CATH URETERAL STENTS CATHETER, MODIFICATION Vas-Cath, Inc. FAD Class II 1991-04-09
K910215 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST Cd Medical, Inc. FKP Class II 1991-04-09
K905217 FORMASURE TEST REAGENT Di-Chem, Inc. LIF Class II 1991-04-09
K910219 LAPAROMED CHOLANGIOGRAM DEVICE Laparomed Corp. FGE Class II 1991-04-08
K910217 MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM Browne Medical Systems, Inc. FAP Class II 1991-04-02
K910931 BILIARY BALLOON DILATATION CATHETER Boston Scientific Corp FGE Class II 1991-04-02
K902227 SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT Serim Research Corp. LIF Class II 1991-04-02
K910285 BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP Browne Medical Systems, Inc. FAP Class II 1991-04-02
K910497 WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE Wilson-Cook Medical, Inc. OCY Class II 1991-04-02
K910022 MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT Medical Marketing Group FCM Class II 1991-04-02
K910728 CLEANFLOW SYSTEM Mitron Technologies, Inc. KQT Class II 1991-04-01
K904849 ORIGINEEDLE(TM) Origin Medsystems, Inc. FHO Class II 1991-03-29
K910493 AVD INTIMAX CHOLANGIOGRAPHY CATHETER Applied Vascular Devices, Inc. FGE Class II 1991-03-28
K904800 SIF-SW Olympus Corp. FDA Class II 1991-03-27
K904799 CHF-B20 CHOLEDOCHOSCOPE Olympus Corp. FBN Class II 1991-03-27
K910196 BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS C.R. Bard, Inc. FGH Class II 1991-03-27
K905738 OPERATIVE CHOLANGIOGRAPHIC CATHETER Applied Vascular Devices, Inc. FGE Class II 1991-03-21
K910722 450CM GUIDE WIRE FOR G.I. USE Terumo Corp. OCY Class II 1991-03-21
K904668 IE MAGNETIC EXTRACTOR Olympus Corp. FCC Class II 1991-03-21
K904646 BCI-100 FECAL INCONTINENCE SYSTEM Biocare Intl. FAP Class II 1991-03-19
K910768 SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE Surgitek Medical Engineering Corp. FGE Class II 1991-03-19
K905282 ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE Frantz Medical Development, Ltd. GCT Class II 1991-03-19
K905088 HOT BIOPSY FORCEPS Esco Precision, Inc. KGE Class II 1991-03-19
K910875 ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE ETHICON, Inc. FDP Class II 1991-03-19
K910332 FLEXIFLO SACKS-VINE GASTROSTOMY KITS Abbott Laboratories KNT Class II 1991-03-19
K905021 ACETATE CONCENTRATES FOR HEMODIALYSIS Medical Components, Inc. KPO Class II 1991-03-15
K904669 BALLOON CATHETERS Olympus Corp. FGE Class II 1991-03-15
K905722 SUTURE APPLIER DEVICE Laparomed Corp. MFJ Class II 1991-03-14
K905289 SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT Medical Engineering Corp. FAD Class II 1991-03-13
K910603 LOOP RETRIEVER Annex Medical, Inc. FFL Class II 1991-03-11
K905556 HIGH SPEED CORE CUT BIOPSY GUN Uni-Quatro Industries Canada, Inc. FCG Class II 1991-03-08
K905557 CCC CROWN-CORE-CUT-NEEDLE Uni-Quatro Industries Canada, Inc. KNW Class II 1991-03-08
K902588 BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD Gambro-Hospal, Inc. KOC Class II 1991-03-07
K905181 NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY Meadox Surgimed, Inc. EZN Class II 1991-03-06
K904233 CONVATEC ABSORBENT BANDAGE Convatec, A Division of E.R. Squibb & Sons EXE Class I 1991-03-06
K904797 SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) Surgitek FBO Class II 1991-03-05
K904793 SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8) Surgitek FGB Class II 1991-03-05
K902564 NEEDLE, DIALYSIS Gainor Medical Europe, Ltd. FIE Class II 1991-03-01
K904406 EER ERECTION ENHANCED RESPONDER Eer, Inc. LKY Class II 1991-02-25
K904638 TROCAR DISPOSABLE L.A.S.E.R., Inc. FBQ Class II 1991-02-21

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