meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
36
Latest Decision
1993-07-02

Clearances · page 76 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K915258 SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM Aqua-Med Systems, Inc. FIP Class II 1993-07-02
K921546 VASOVASOSTOMY SET Cook Urological, Inc. KOA Class I 1993-07-02
K924134 LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS Leisegang Medical, Inc. GCS Class II 1993-07-02
K914210 VAS-CATH DUALATOR(TM) VESSEL DILATOR Vas-Cath, Inc. FKA Class II 1993-07-01
K931340 GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR Baxter Healthcare Corp GCS Class II 1993-07-01
K931156 CONE CATH Sierra Laboratories, Inc. EXJ Class I 1993-07-01
K914162 VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS Vas-Cath, Inc. LFJ Class II 1993-07-01
K924916 ENDOPATH ENDOSCOPIC TISSUE RETRACTOR Ethicon Endo-Surgery, Inc. GCJ Class II 1993-06-25
K930508 HIFLO FILTERED INSUFFLATION TUBING W. J. Medical Instruments, Inc. FCX Class II 1993-06-25
K931018 KARL STORZ 495N SERIES FIBER OPTIC LIGHT CABLES KARL STORZ Endoscopy-America, Inc. GCJ Class II 1993-06-25
K925147 ORC 10.0MM SUCTION PROBE O.R. Concepts, Inc. GCJ Class II 1993-06-25
K926444 FUJINON VIDEO LAPAROSCOPE, MODIFICATION Fujinon, Inc. GCJ Class II 1993-06-25
K924196 LAPAROSCOPIC NEEDLE HOLDER Nusurg, Inc. FHQ Class I 1993-06-25
K915841 BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC C.R. Bard, Inc. KNT Class II 1993-06-25
K926010 SURGICAL DISSECTOR WITH CANNULA General Surgical Innovations GCJ Class II 1993-06-25
K930511 STEALTH SURGICAL IRRIGATOR ASPIRATOR W. J. Medical Instruments, Inc. GCJ Class II 1993-06-25
K921315 PENTAX XENON LIGHT SOURCE Pentax Precision Instrument Corp. GCT Class II 1993-06-25
K931650 MICROVASIVE INSURG GEENEN CBD GUIDE WIRE Boston Scientific Corp OCY Class II 1993-06-25
K931142 INSTRUMENTS FOR LAPAROSCOPIC USE Li Medical Technologies, Inc. GCJ Class II 1993-06-25
K930550 ECO LIGATING CLIP Weck Endoscopy GCJ Class II 1993-06-24
K926335 IDEAS PEANUT WAND Ideal Medical, Inc. GCJ Class II 1993-06-24
K931277 HOLLISTER PREMIUM URINE COLLECTOR Hollister, Inc. EXI Class I 1993-06-23
K924755 CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION Convatec, A Division of E.R. Squibb & Sons EXI Class I 1993-06-22
K931111 ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA Ethicon Endo-Surgery, Inc. GCJ Class II 1993-06-22
K932282 ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE Ethicon Endo-Surgery, Inc. GCJ Class II 1993-06-22
K931237 ENDOPATH* DISPOSABLE INTRODUCER ETHICON, Inc. GCJ Class II 1993-06-22
K931238 ENDOPATH DISPOSABLE KNOT PUSHER ETHICON, Inc. GCJ Class II 1993-06-22
K930933 ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS ETHICON, Inc. GCJ Class II 1993-06-22
K930147 SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY Davol, Inc. GCJ Class II 1993-06-22
K923906 FOLEY INSERTION TRAY Kit Pak, Inc. KOD Class II 1993-06-22
K924383 SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO Synectics-Dantec FAP Class II 1993-06-18
K926088 FST CATH UD-DUAL DUAL PRESSURE CATHETER Fiberoptic Sensor Technlogies, Inc. FEN Class II 1993-06-18
K931382 11274 AC FLEXINBLE CHOLEDOCHOSCOPE KARL STORZ Endoscopy-America, Inc. FBN Class II 1993-06-18
K922051 KIT PAK'S FLUSHING KIT Kit Pak, Inc. KOD Class II 1993-06-17
K923940 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE American Healthcare Corp. EYN Class II 1993-06-17
K923941 IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE American Healthcare Corp. EYN Class II 1993-06-17
K923938 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER American Healthcare Corp. EYN Class II 1993-06-17
K922398 4 SURE TM ENEMA BAG SET Boston Pacific Medical, Inc. FCE Class I 1993-06-17
K923939 IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER American Healthcare Corp. EYN Class II 1993-06-17
K931421 DISPOSABLE STEERABLE ANGIOSCOPE Endovascular, Inc. LYK Class II 1993-06-16
K931459 KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER Kendall Healthcare Products Co. Div.Of Tyco Health KNX Class II 1993-06-14
K925067 SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG Simport Plastics, Ltd. KNX Class II 1993-06-10
K911230 RS-1000 Cp Medical KOC Class II 1993-06-09
K930349 STONE RETRIEVAL BASKET Endomedix FFL Class II 1993-06-09
K930201 ACECUT SUTOMATIC BIOPSY SYSTEM Meadox Surgimed, Inc. KNW Class II 1993-06-09
K930352 HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. Ultracision, Inc. GCJ Class II 1993-06-08
K930330 ENDOSCOPIC NEEDLEHOLDER, MODIFICATION Holmed Corp. FHQ Class I 1993-06-08
K931259 ENDOSCOPIC OR THORASCOPIC FORCEPS T. Korossurgical Instruments Corp. GCJ Class II 1993-06-08
K923031 ENDOSNARE Cook Urological, Inc. FDI Class II 1993-06-07
K930464 BLUNT DISSECTING SCISSORS Surgical Technologies, Inc. GCJ Class II 1993-06-04
K921208 ACCU-BEAM TUBE SET Tti Medical GCJ Class II 1993-06-01
K930427 STD IRRIGATION PUMP Std Mfg., Inc. GCJ Class II 1993-06-01
K923496 URINARY CARE SUPPLIES Orion Life Systems, Inc. KNY Class II 1993-05-27
K923538 MON-A-THERM FOLEY KIT Mallinckrodt Medical FCM Class II 1993-05-27
K920706 MAGNETIC POINT GUARD FOR SURGICAL NEEDLES Retrax FHQ Class I 1993-05-26
K921925 MANUAL SURGICAL INSTRUMENTS 3M Health Care, Ltd. GCJ Class II 1993-05-26
K924440 U.S. MEDICAL PS-7000 DIALYSIS SCALE U.S. Medical Corp. KOE Class II 1993-05-26
K925276 M.I.S. TROCAR-CANNULA M.I.S. Technology, Inc. GCS Class II 1993-05-24
K926570 HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 Hollister, Inc. KNX Class II 1993-05-21
K930466 COMPRESSION CLAMP Surgical Technologies, Inc. GCJ Class II 1993-05-21
K926369 WALTHER CATHETERS, MALE, FEMALE Thomasville Medical Assoc. GBM Class II 1993-05-21
K930467 BABCOCK FORCEPS, GRASPING FORCEPS, NEEDLE HOLDER Surgical Technologies, Inc. GCJ Class II 1993-05-21
K930465 WIRE GUIDED OVAL DILATORS Surgical Technologies, Inc. GCJ Class II 1993-05-21
K926078 DMI TOCAR AND CANNULA SYSTEM Diversified Medical Instruments, Inc. GCJ Class II 1993-05-17
K925790 EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S Deroyal Industries, Inc. EYC Class II 1993-05-17
K931272 MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDUR Minimally Invasive Surgical Technologies, Inc. GCJ Class II 1993-05-17
K925699 HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC. Ultracision, Inc. GCJ Class II 1993-05-17
K924931 NEEDLE, PNEUMOPERITONEUM, SPRING LOADED Lpc, Inc. GCJ Class II 1993-05-17
K926341 UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT Unisurge, Inc. GCJ Class II 1993-05-17
K921295 INTRAVENOUS CATHETERS MODIFICATIONS Critikon Company, LLC FGO Class II 1993-05-17
K930827 BARD STABILIZING CANNULA C.R. Bard, Inc. FAJ Class II 1993-05-14
K930556 NIGHT URINARY DRAINAGE BEDSIDE BAG Ezmt Valve Co., Inc. EYZ Class I 1993-05-14
K931276 MIST RATCHETED FORCEPS FOR LAPAROSCOPIC/ENDOSCOPIC Minimally Invasive Surgical Technologies, Inc. GCJ Class II 1993-05-13
K921457 IRRIGATION PUMPS AND TUBING AND SUCTION TUBING American Surgical Instruments Corp. GCJ Class II 1993-05-13
K931181 VESITEC SUTURE PASSER Vesitec Medical, Inc. KOA Class I 1993-05-12
K925914 PRE-TIED LOOP SUTURE CANNULA ETHICON, Inc. GCJ Class II 1993-05-12
K923692 STOMA MEASURING DEVICE Applied Medical Technologies KNT Class II 1993-05-07
K931092 ENDOSCOPIC RETRACTOR L.A.S.E.R., Inc. GCJ Class II 1993-04-30
K926214 GUIDE WIRE FOR LAPOROSCOPIC USE Terumo Medical Corp. GCJ Class II 1993-04-29
K931337 AUTO SUTURE DILATING CANNULA United States Surgical, A Division of Tyco Healthc GCJ Class II 1993-04-29
K930022 SPHINCTEROTOME Boston Scientific Corp FDI Class II 1993-04-27
K930935 ENDOPATH TISSUE EXTRACTION CANNULA ETHICON, Inc. GCJ Class II 1993-04-27
K922319 OMNI LAPAROSCOPE Expanded Optics, Inc. GCJ Class II 1993-04-23
K925932 CANUSEAL Lap Associates of Nashville, Ii, Inc. GCJ Class II 1993-04-23
K925860 MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL United States Surgical, A Division of Tyco Healthc GCJ Class II 1993-04-23
K922987 LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. Biosearch Medical Products, Inc. GCJ Class II 1993-04-23
K925129 SELECTOR Spembly Medical , Ltd. GCJ Class II 1993-04-23
K924281 HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY Ultracision, Inc. GCJ Class II 1993-04-23
K930083 EMS BIOPSY INSTRUMENT Engineered Medical Systems KNW Class II 1993-04-21
K923470 DISPOSABLE HOT BIOPSY FORCEPS Wilson-Cook Medical, Inc. KGE Class II 1993-04-21
K930569 LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM Laparomed Corp. GCJ Class II 1993-04-20
K920262 ONAT BALLOONED NASOGASTRIC TUBE Macdonald Medical Devices, Inc. KNT Class II 1993-04-20
K926223 ENDOSCOPE AND ACCESSORIES Weck Endoscopy GCJ Class II 1993-04-20
K924761 STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD Richard-Allan Medical Ind., Inc. GCJ Class II 1993-04-20
K930496 GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS Birtcher Medical Systems, Inc. GCI Class II 1993-04-20
K920611 MARLOW LAPAROSCOPIC GRASPING FORCEP Marlo Surgical Technology GCJ Class II 1993-04-20
K930241 OLYMPUS DISPOSABLE BIOPSY FORCEPS Olympus Corp. KNW Class II 1993-04-20
K925281 KIT PAK URINARY CARE SUPPLIES Kit Pak, Inc. KNY Class II 1993-04-19
K924135 FLEXIBLE URETERONEPHROSOCOPE Applied Medical Resources FEB Class II 1993-04-14
K923995 URODYNAMICS TUBING KITS #5161, #5150, #7170 Advanced Medical Products, Inc. FAP Class II 1993-04-08

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