meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
45
Latest Decision
1981-09-29

Clearances · page 106 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K812685 ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE Ericka FJK Class II 1981-09-29
K812326 SORENSON SUBCLAVIAN CATHETER SSC-8 Sorensen Research LFJ Class II 1981-09-25
K811706 LACTIC ACID DIALYSATE ADDITIVE Edlaw Pharmaceuticals, Inc. KPO Class II 1981-09-24
K812162 HEMODIALYSIS TRANSDUCER PROTECTOR Membrana FIB Class II 1981-09-24
K812621 DELTA-A.V. FISTULA CANNULATION SET Amisco Trading Corp. FIE Class II 1981-09-24
K812622 HEMODIALYSIS VENOUS & ARTERIAL SET Amisco Trading Corp. FKH Class II 1981-09-24
K812427 CARTMILL/BARRY FEEDING TUBE Impra, Inc. KNT Class II 1981-09-23
K812582 CANCEL Bio Systems, Inc. EXB Class I 1981-09-23
K812249 SKIN ADHESIVE-50XX Manfred Sauer Corp. KNX Class II 1981-09-23
K811830 C-DAK DUO-FLUX ARTIFICIAL KIDNEY Cordis Corp. KDI Class II 1981-09-21
K811863 STERI-TRACT Rogo Ent. KDJ Class II 1981-09-21
K812353 KF-E SERIES OF HOLLOW FIBER DIALYZERS Medisystems Corp. FJI Class II 1981-09-16
K811974 MICROCOIL 150 DIALYZER Erika, Inc. FHS Class II 1981-09-16
K812507 THE KEOFEED STOMACH TUBE Hedeco KNT Class II 1981-09-14
K812130 SPIKE GUARD Clinipad Corp. KDJ Class II 1981-09-09
K812177 LIFE-TECH #1857 PRESSURE/POLOT MODULE Life-Tech Instruments, Inc. EXQ Class II 1981-09-09
K811925 UROFLOWMETER C.R. Bard, Inc. FFG Class II 1981-09-08
K811839 MEDISYSTEM NEGATIVE PRESSURE Medisystems Corp. FJK Class II 1981-09-08
K811838 MEDISYSTEMS FISTULA NEEDLE Medisystems Corp. FIE Class II 1981-09-08
K812289 CELESTIN DILATOR Inmed Corp. KNQ Class II 1981-09-01
K811851 S-610 SHUNT ADAPTOR SET Dravon Medical, Inc. KNR Class II 1981-08-31
K811944 GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER Gambro, Inc. KDI Class II 1981-08-31
K811986 THE AMP 80/2 PEDIATRIC CYCLER SYSTEM American Medical Products, Inc. FKX Class II 1981-08-31
K812294 CONVEEN URISHEATH & CONVEEN URILINER Telcam Medical Devices, Inc. KNX Class II 1981-08-31
K812336 COBE PPD 1.9 Cobe Laboratories, Inc. FJG Class II 1981-08-31
K812102 O.N.A.T. Latex Medical Devices, Inc. KNT Class II 1981-08-31
K812279 ENTER-A1 ENTERIC FEEDING TUBE Medi-Tech, Inc. KNT Class II 1981-08-25
K811968 VIVONEX TUNGSTEN TIP Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1981-08-25
K812107 RENALAB TRANSDUCER PROTECTOR, .22 MICRON Renalab FIB Class II 1981-08-20
K812250 CONDOM-52.XX Manfred Sauer Corp. KNX Class II 1981-08-20
K812251 DISPOSABLE URINE GAB-70.XX Manfred Sauer Corp. KNX Class II 1981-08-20
K812252 LATEX LEG BAG-57.XX Manfred Sauer Corp. KNX Class II 1981-08-20
K812103 ESOPHAGEAL MOTILITY APPARATUS Honeywell, Inc. FFX Class II 1981-08-13
K812178 LIFE-TECH #'S 1106/1156 UROLABS Life-Tech Instruments, Inc. FAP Class II 1981-08-13
K811083 ESOPHAGEAL MOTILITY PROBE Konigsberg Instruments, Inc. FFT Class I 1981-08-13
K811859 BACTASHIELD Tri-Med, Inc. FIB Class II 1981-08-07
K811981 ISOLATER THP Tri-Med, Inc. KOC Class II 1981-08-04
K811892 CORDIS DOW SERA FLO TM TRANSDUCER PROT Cordis Corp. FIB Class II 1981-07-31
K811170 D-3160 SORBENT CARTRIDGE Organon Teknika Corp. FKT Class II 1981-07-31
K811973 FORDER RETRACTOR Surgemed Marketing, Inc. KOA Class I 1981-07-31
K812057 VANCE CYSTOSCOPIC Vance Products, Inc. FBK Class II 1981-07-31
K812058 AKRON URINARY DRAINAGE BAT Latex Ind., Inc. KNX Class II 1981-07-31
K811977 HEMASITE ACCESS MONITOR (TENT.) #RS-8200 Renal Systems, Inc. KOC Class II 1981-07-31
K811384 HEMASITE VASCULAR ACCESS SHUNT Renal Systems, Inc. FIQ Class II 1981-07-31
K811277 CATH-DAP Northwest Alabama Urological Assoc. KOD Class II 1981-07-20
K811683 ENTRI ENTERNAL FEEDING SET Biosearch Medical Products, Inc. KNT Class II 1981-07-15
K811779 ROSS-EMERSON PUMP, MODEL 55-R J. H. Emerson Co. KQT Class II 1981-07-13
K811591 B-D DRAKE WILLOCK #7000 SERIES ULTRAF Bd Becton Dickinson Vacutainer Systems Preanalytic FKP Class II 1981-07-10
K811533 MGN FEEDING TUBE Mgn Medical Manufacturing, Inc. KNT Class II 1981-07-10
K811833 VNACE FASCIAL DILATOR SET Vance Products, Inc. KOE Class II 1981-07-10
K811678 GAMBRO WATER PURIFICATION MONITOR WRD Gambro, Inc. FIP Class II 1981-07-10
K811183 DENVER PERITONEO-VENOUS SHUNT Denver Biomedicals, Inc. KPM Class II 1981-07-01
K811580 GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET Porges Catheter Corp. FFL Class II 1981-06-26
K811693 FORDER RETRACTOR Dacomed Corp. KOA Class I 1981-06-26
K811639 ETHIX FEEDING TUBES POLYURETHANE/RADIOP. Ethox Corp. KNT Class II 1981-06-26
K810739 SUCTION WOUND DRAINAGE DEVICE The Urology Group KQT Class II 1981-06-26
K811444 MODEL DM-333 DIALYSIS CONTROL STATION Extracorporeal Medical Specialities, Inc. FKQ Class II 1981-06-23
K811061 AUTOMATED GASTRIC LAVAGE Emergency Medicine KNT Class II 1981-06-23
K811535 MODEL FUS-1, FLEXIBLE URETEROSCOPE American Optical Corp. FGB Class II 1981-06-23
K811457 MODEL RS-8100 Rinal Systems, Inc. KOC Class II 1981-06-23
K811266 QUINTON CATHETER FINGER GRIP Quinton, Inc. FKO Class II 1981-06-18
K810605 CHEMATIC BICARBONATE DIALYSATE SYSTEM Trimedyne, Inc. FKR Class II 1981-06-16
K811240 SUR-FIT LOOP OSTOMY O.R. SET E. R. Squibb & Sons, Inc. EXB Class I 1981-06-16
K811294 GAMBRO PERITONEAL DIALYSIS FLUID LINES Gambro, Inc. KDJ Class II 1981-06-12
K811440 EXP 600 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. FJG Class II 1981-06-12
K811469 MMG URINARY DRAINAGE TUBING Medical Marketing Group KNX Class II 1981-06-12
K811439 EXP 200 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. FJG Class II 1981-06-12
K811454 VANCE PROSTATIC ASPIRATION SET Vance Products, Inc. KNW Class II 1981-06-09
K811300 ECONOMY OPEN END DRAINAGE BAG Economy Plus EXB Class I 1981-06-09
K810066 COBE PPD .8 Cobe Laboratories, Inc. FJG Class II 1981-06-09
K811239 SUR-FIT DISPOSABLE CONVEX INSERT E. R. Squibb & Sons, Inc. EXB Class I 1981-06-09
K810726 FORMULATION CHANGE IN UNITED SKIN BARR Howmedica Corp. EXB Class I 1981-06-02
K811160 SUR-FIT IRRIGATION SLEEVE E. R. Squibb & Sons, Inc. EXD Class II 1981-06-02
K811292 PARALLEL PLATE DIALYZER HOLDER Extracorporeal Medical Specialities, Inc. FKI Class II 1981-06-02
K810979 ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT Arrow Intl., Inc. KNT Class II 1981-06-02
K811223 VASOVASOSTOMY STABILIZER PLATFORM DEV Biomet, Inc. KOA Class I 1981-05-21
K811163 SUR-FIT DISPOSABLE FANGE CAP E. R. Squibb & Sons, Inc. EXB Class I 1981-05-21
K810915 THE SCOTT DIALMENZENSERT Lone Star Medical Products, Inc. KOA Class I 1981-05-08
K802828 LIXIVITRON United Medical LIF Class II 1981-05-08
K810683 CAPD CATHETER ADAPTER American Mcgaw FKX Class II 1981-05-08
K810837 CYBER 80 HEMODIALYZER Cyberex Corp. FJG Class II 1981-05-05
K810645 SELECT-A-FLOW COLLECTOR Wenmar Intl. Corp. KNX Class II 1981-05-05
K802297 PORTADIAL CARRY-ON KIDNEY MACHINE Alan P. Kendal, Ph.D. FKQ Class II 1981-05-01
K810996 ENTERNAL PUMP SET W/INTEGRAL CONTAINER Abbott Laboratories KNT Class II 1981-04-29
K810612 HEMOPHRON Renal Devices, Inc. FKQ Class II 1981-04-29
K810840 AMP PERITONEAL DIALYSIS PREP KIT American Medical Products, Inc. KDJ Class II 1981-04-29
K810925 NATURALYTE BICARBONATE DIALYSATE CONCEN. Erika, Inc. KPO Class II 1981-04-23
K810690 CURITY 100% SILICONE SAFETY INDICATOR The Kendal Co. KOD Class II 1981-04-23
K810527 CHEM-DIALYTE CONCENTRATES Luchem Pharmaceuticals, Inc. KPO Class II 1981-04-23
K810573 TUBE FEEDING SET Harvard Laboratories KNT Class II 1981-04-23
K810824 ERIKA HEPARIN INFUSION ADAPTOR Erika, Inc. FJK Class II 1981-04-17
K810812 DRAINING-WOUND MGMT. SYSTEM Johnson & Johnson Professionals, Inc. EXB Class I 1981-04-17
K810854 KANGAROO NASOGASTRIC FEEDING TUBE Chesebrough-Pond'S U.S.A. Co. KNT Class II 1981-04-17
K810823 ERIKA EXTENSION SETS Erika, Inc. FJK Class II 1981-04-17
K810757 I.V. ADMINISTRATION SET American Mcgaw FDA Class II 1981-04-08
K810818 KEY-MED FIBRESCOPE DISINFECTION TROLLEY Keymed, Inc. FEB Class II 1981-04-08
K810709 HOLLISTER SKIN BARRIER A Hollister, Inc. EXB Class I 1981-04-07
K810506 PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT Propper Mfg. Co., Inc. OCX Class II 1981-04-07
K810250 TRAY, IRRIGATION Megaplast, Inc. KNT Class II 1981-04-07
K810807 HOLLISEAL OSTOMY SKIN BARRIER Hollister, Inc. EXB Class I 1981-04-07

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