meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
40
Latest Decision
1992-05-04

Clearances · page 79 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920515 INSERTION Accurate Surgical Instruments Co. FJS Class II 1992-05-04
K920894 DECOMPRESSION TUBES Applied Medical Technologies KNT Class II 1992-04-28
K914624 PH METER, MODIFICATION Synectics-Dantec FFT Class I 1992-04-28
K921233 BARD 4-WIRE URETEROSCOPIC STONE C.R. Bard, Inc. FFL Class II 1992-04-27
K915751 URETEROMAT 4400 F.M. Wiest USA, Inc. EZN Class II 1992-04-24
K921026 PRESSURE GAUGE Hobbs Medical, Inc. KNT Class II 1992-04-24
K905745 AMETEC MASY MODULAR ANGIOSCOPE SYSTEM American Medical Technology, Inc. LYK Class II 1992-04-23
K914936 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET Akcess Medical Products, Inc. LFK Class II 1992-04-23
K903440 VIVAMED FISTULA NEEDLE S.S. Ent. FIE Class II 1992-04-20
K920420 DURA II PENILE PROSTHESIS Dacomed Corp. FAE Class II 1992-04-16
K920750 BARD URETEROSCOPE DEFLECTION MODULE C.R. Bard, Inc. FGB Class II 1992-04-16
K920139 GLEESON CLOT-BUSTER Conmedcorp GCI Class II 1992-04-15
K915110 FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT Abbott Laboratories KNT Class II 1992-04-14
K914908 QUICVAGE PLUS Autovage KDH Class II 1992-04-13
K914826 AKCESS-CATH KIT Akcess Medical Products, Inc. LFJ Class II 1992-04-10
K921047 MODEL 8100 URODYNAMICS MEASURING SYSTEM Browne Medical Systems, Inc. FAP Class II 1992-04-10
K920991 IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION Browne Medical Systems, Inc. FAP Class II 1992-04-10
K920992 PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED Browne Medical Systems, Inc. FAP Class II 1992-04-10
K914123 SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS Serim Research Corp. LIF Class II 1992-04-09
K915129 CATHETER WITH INTRODUCER AND SYRINGES Utah Pioneer Medical, Inc. GCA Class II 1992-04-08
K921086 WOM LAPAROFLATOR ELECTRONIC W.O.M. GmbH GCJ Class II 1992-04-07
K915372 MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY Unisurge, Inc. GCJ Class II 1992-04-06
K915286 LAP TISSUE COLLECTION BAG Baxter Healthcare Corp GCJ Class II 1992-04-06
K912374 BARD(R) UROTACK(R) 210 MONITORING SYSTEM C.R. Bard, Inc. KOC Class II 1992-03-31
K915343 URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Uresil Corp. GCA Class II 1992-03-31
K920089 MONOPOLAR COAGULATING POLYPECTOMY SNARE Everest Medical Corp. KNS Class II 1992-03-31
K913361 DRAIN/PRIMING/RECIRCULATION BAG Haemotronic, Inc. KOC Class II 1992-03-30
K914755 DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT Davol, Inc. GCA Class II 1992-03-30
K915215 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS Akcess Medical Products, Inc. LFK Class II 1992-03-27
K914922 UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG Charles L. Rose and Co., Inc. GCJ Class II 1992-03-26
K921071 DENTOLOCK Dentmed , Ltd. KOB Class II 1992-03-26
K914690 LM15(TM), CATALOG NUMBER - 523821 Edward Weck, Inc. GCJ Class II 1992-03-23
K915538 OVER THE WIRE STONE BASKET Medical Dynamics, Inc. LQR Class II 1992-03-20
K914905 ENTRAC(TM) URETHRAL MEASURING CATHETER American Medical Systems, Inc. GBM Class II 1992-03-20
K914020 MODIFIED ASAHI PAN-SERIES HEMOFILTERS Asahi Medical Co., Ltd. KDI Class II 1992-03-20
K915099 ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN ETHICON, Inc. GCJ Class II 1992-03-19
K920030 SURESEAL ENDOSCOPIC VALVE Applied Urology, Inc. ODC Class II 1992-03-18
K915854 ENDOSCOPIC TRANSLUMINATOR O.R. Concepts, Inc. GCJ Class II 1992-03-18
K915392 ACCENT DG BALLOON URTERAL DILATOR SET, 10CM Cook Urological, Inc. EZN Class II 1992-03-18
K912935 AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS American Medical Systems, Inc. FAE Class II 1992-03-18
K915628 DEXTROLYTE II PERITONEAL DIALYSIS PUMP National Medical Care, Medical Products Div., Inc. KDJ Class II 1992-03-16
K914363 PERITONEAL DIALYSIS CYCLER SET National Medical Care, Medical Products Div., Inc. KDI Class II 1992-03-16
K915762 POOLE TIP SUCTION PROBE O.R. Concepts, Inc. GCI Class II 1992-03-13
K915813 ACKRAD ERCP CONTRAST DELIVERY SET Ackrad Laboratories FGE Class II 1992-03-11
K915408 BIPOLAR ENDOSTASIS PROBE, BEST (TM) Medical Devices, Inc. KNS Class II 1992-03-11
K915544 LAPAROSCOPY SCISSORS C.R. Bard, Inc. GCJ Class II 1992-03-09
K913997 SAECG CARDIOGRAPH MODEL M1754A Hewlett-Packard Co. KNT Class II 1992-03-06
K914375 NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE Sherwood Medical Co. KNT Class II 1992-03-06
K915504 GAMBRO LUNDIA ALPHA HEMODIALYZERS C.G.H. Medical, Inc. FJG Class II 1992-03-06
K915506 LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT United States Endoscopy Group, Inc. GCA Class II 1992-03-06
K914112 METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE Annex Medical, Inc. FGO Class II 1992-02-28
K914111 METAL URETERAL BASKET STONE DISLODGER, HELICAL Annex Medical, Inc. FGO Class II 1992-02-28
K920040 INTRADUCER Taut, Inc. GCJ Class II 1992-02-28
K914110 GRASPING FORCEPS Annex Medical, Inc. FGO Class II 1992-02-28
K914492 GASTROINTESTINAL TUBE AND ACCESSORIES Sandoz Nutrition FPD Class II 1992-02-25
K913407 NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE Sandoz Nutrition FPD Class II 1992-02-25
K915439 NASOGASTRIC FEEDING TUBE KITS Sandoz Nutrition FPD Class II 1992-02-25
K905809 NMC CYCLER MACHINE National Medical Care, Medical Products Div., Inc. FKX Class II 1992-02-25
K915484 URETHRALPRESSURE PROFILE CATHETER Life-Tech Intl., Inc. FAP Class II 1992-02-24
K915438 FEEDING TUBE Y-PORT CONNECTOR Sandoz Nutrition FPD Class II 1992-02-24
K914580 DRS-4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. LIF Class II 1992-02-24
K914215 SELECTACUT BIOPSY DEVICE Biomni Medical Systems, Inc. KNW Class II 1992-02-24
K920403 XENON ARC ENDOSCOPE LIGHT SOURCE Medical Device Inspection Co., Inc. GCJ Class II 1992-02-21
K915443 URODYNAMIC CATHETER Cook Urological, Inc. FAP Class II 1992-02-19
K915304 ABBOTT SMART CAP Abbott Laboratories KDJ Class II 1992-02-19
K914699 URESIL FIXATION DEVICE Uresil Corp. FGE Class II 1992-02-19
K915719 ANGEION ENDOSCOPIC VALVE SEAL Angeion Corp. ODC Class II 1992-02-18
K914504 CYTOLOGY BRUSH Surgitek Medical Engineering Corp. FDX Class II 1992-02-18
K914874 MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE Manan Medical Products, Inc. KNW Class II 1992-02-18
K913701 MOSS - ANCHOR SET Moss Medical Products FPD Class II 1992-02-14
K913476 GI BLEEDER/OD SET Icu Medical, Inc. KNT Class II 1992-02-12
K912772 SUPERLOGGER Sandhill Scientific, Inc. FFT Class I 1992-02-07
K913736 DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST Biosearch Medical Products, Inc. FAP Class II 1992-02-07
K912892 AUTO-VAC BIOPSY NEEDLE Angiomed GmbH & Co. Medizintechnik KG KNW Class II 1992-02-07
K915171 LOPEZ VALVE TM II Icu Medical, Inc. KNT Class II 1992-02-07
K913487 RIWOLITH 2280 Richard Wolf Medical Instruments Corp. FFK Class II 1992-02-05
K915246 CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) Coloplast A/S EXI Class I 1992-02-05
K914933 HEART PACK III Westmark Hospital Supplies KOD Class II 1992-01-31
K915681 CHOLEDOCHOSCOPE Applied Laparoscopy FBN Class II 1992-01-30
K915458 URETEROSCOPE Psi Medical Products, Inc. FGB Class II 1992-01-30
K914495 E.R.C.P. CATHETER Surgitek Medical Engineering Corp. FGE Class II 1992-01-30
K912851 NAUDE URETHRAL STENT Cook Urological, Inc. KOD Class II 1992-01-30
K913986 CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM Medical Dynamics, Inc. FGE Class II 1992-01-28
K914570 DISPOSABLE VASCULAR ANGIOSCOPE Nobles-Lai LYK Class II 1992-01-27
K915360 LAPAROSCOPIC SNARE POUCH United States Endoscopy Group, Inc. GCJ Class II 1992-01-27
K913341 BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER C.R. Bard, Inc. EZC Class II 1992-01-27
K914861 EVACUATION KIT #7-510-14 Northgate Technologies, Inc. GCJ Class II 1992-01-27
K914907 QUICVAGE Autovage KDH Class II 1992-01-24
K914557 ECONOAID Gromedco LKY Class II 1992-01-23
K912859 FUJINON EVL-F Fujinon, Inc. GCJ Class II 1992-01-23
K915616 URIHESIVE STRIP Convatec, A Division of E.R. Squibb & Sons EXI Class I 1992-01-23
K915298 SUCTION/IRRIGATION CANNULA; CATLOG #532.00 Lifeguard Medical Products, Inc. GCJ Class II 1992-01-23
K913169 DANTEC UD 5500 MK2 Dantec Medical, Inc. FAP Class II 1992-01-23
K914084 ENDOSCOPES Precise Optics GCJ Class II 1992-01-22
K915239 ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR ETHICON, Inc. GCJ Class II 1992-01-15
K914869 MARLOW LAPAROSCOPIC SCISSORS Marlo Surgical Technology GCJ Class II 1992-01-15
K913784 DOBBHOFF(R) SINGLE PASS PEG KIT Biosearch Medical Products, Inc. KNT Class II 1992-01-15
K904940 OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES Olympus Corp. FJL Class II 1992-01-13
K910173 SELECTRA AND TUBING SETS Medionics International , Ltd. FKX Class II 1992-01-13
K915142 AMCATH DISPOSABLE BIOPSY FORCEPS Intl. Medical, Inc. FCF Class II 1992-01-10

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