meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
54
Latest Decision
1989-06-22

Clearances · page 88 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K891062 TERUMO AV FISTULA NEEDLE SET Terumo Medical Corp. FIE Class II 1989-06-22
K890047 VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM Vascucare, Inc. LYK Class II 1989-06-20
K890424 ENTERAL FEEDING CONTAINER Multi-Med, Inc. KNT Class II 1989-06-14
K893439 HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C Medical Components, Inc. LFJ Class II 1989-06-13
K890072 PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE Medireach, Inc. KNY Class II 1989-06-12
K891477 CLIRANS HOLLOW FIBER HEMODIALYZER (WET) Terumo Medical Corp. FJI Class II 1989-06-09
K893188 QUINTON SINGLE LUMEN CATHETER Quinton, Inc. MPB Class II 1989-06-08
K891755 DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K Akcess Medical Products, Inc. LFJ Class II 1989-06-08
K893478 DA-16 AND DA-24 SHUNT ADAPTERS Akcess Medical Products, Inc. FKN Class II 1989-06-08
K893438 T SERIES VESSEL TIPS Akcess Medical Products, Inc. FKW Class II 1989-06-08
K891753 DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 Akcess Medical Products, Inc. LFJ Class II 1989-06-08
K893231 DELCLAMP Delmed, Inc. KDJ Class II 1989-06-08
K891339 IRRI-FLO IRRIGATION DELIVERY SYSTEM Surgitek OCX Class II 1989-06-02
K890430 ENTAINER(TM) ENTERAL FEEDING CONTAINER Entech, Inc. KNT Class II 1989-06-02
K885255 MDL-1 LASERTRIPTER(TM) Candela Laser Corp. FFK Class II 1989-06-01
K890629 ESOPHAGEAL OVERTUBE Gastrotech, Inc. FED Class II 1989-05-31
K891686 LIB SYSTEM, BABY/ADULT DIAPER Intera Corp. EYQ Class I 1989-05-31
K892334 LEONARD TUBE Surgidyne, Inc. KDH Class II 1989-05-31
K892218 ENDO-SPONGE Endovations MNL Class I 1989-05-31
K891187 TECNOL NASO-GASTRIC TUBE HOLDER Tecnol New Jersey Wound Care, Inc. BSS Class II 1989-05-30
K890284 URODEC 500 Ferguson Medical FES Class II 1989-05-30
K885345 HEALTHSHIELD Jonas, Inc. KPN Class II 1989-05-24
K892648 MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 Boston Scientific Corp OCY Class II 1989-05-24
K890151 ENTERAL BAG/SET Ashley Health Care, Inc. KNT Class II 1989-05-23
K890465 CLOSED SYSTEM URINARY DRAINAGE BAG Cypress Medical Products, Ltd. EYZ Class I 1989-05-23
K890396 EXTERNAL FEEDING SET FOR PUMP USE Multi-Med, Inc. FPD Class II 1989-05-23
K891178 TECNOL SECURE-ALL TUBE HOLDER Tecnol New Jersey Wound Care, Inc. EYZ Class I 1989-05-23
K892431 KENDALL CURITY FEEDING TUBES The Kendal Co. FPD Class II 1989-05-19
K892871 PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD National Medical Care, Medical Products Div., Inc. KDJ Class II 1989-05-18
K892375 MODIFIED AM-SERIES DIALYZERS Asahi Medical Co., Ltd. FJI Class II 1989-05-18
K892374 NEW AM-SERIES DIALYZERS Asahi Medical Co., Ltd. FJI Class II 1989-05-18
K892872 PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD National Medical Care, Medical Products Div., Inc. KDJ Class II 1989-05-18
K892870 PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD National Medical Care, Medical Products Div., Inc. KDJ Class II 1989-05-18
K892887 ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA Akcess Medical Products, Inc. FIQ Class II 1989-05-15
K890824 FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM Fresenius USA, Inc. FKP Class II 1989-05-11
K892523 GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY Gambro, Inc. FJI Class II 1989-05-11
K890329 FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM Fresenius USA, Inc. FIL Class II 1989-05-11
K891327 NICKLE-TITANIUM ORTHODONTIC WIRE American Orthodontics FJF Class II 1989-05-10
K892542 RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU Zinnanti Surgical Instruments, Inc. FFN Class I 1989-05-09
K892550 BEST COLON CLAMP Zinnanti Surgical Instruments, Inc. FFN Class I 1989-05-09
K890448 LIGHT SOURCE, ENDOSCOP, XENON ARC Mira, Inc. FFS Class II 1989-05-08
K891109 PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE Concept, Inc. KNT Class II 1989-05-08
K892433 KENDALL CURITY URINARY DRAINAGE BAGS The Kendal Co. KNX Class II 1989-05-05
K892667 SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 Akcess Medical Products, Inc. FKN Class II 1989-05-04
K892383 BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET Porges Corp. FGE Class II 1989-05-04
K891777 PRO-CUT BIOPSY NEEDLE Teknar, Inc. FCG Class II 1989-05-04
K892663 S-100 ALLEN-BROWN SHUNT Akcess Medical Products, Inc. FIQ Class II 1989-05-04
K892384 BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER Porges Corp. FGE Class II 1989-05-04
K892666 SAF-T-SHUNT, S-300 SERIES Akcess Medical Products, Inc. FIQ Class II 1989-05-04
K880343 BURNEY GALLBLADDER CATHETER KIT Mallinckrodt Critical Care FGE Class II 1989-05-01
K890870 BARD GASTROSTOMY FEEDING DEVICE C.R. Bard, Inc. KNT Class II 1989-04-27
K891125 CONSTRICTOR RING FOR PENILE ERECTION Performance, Inc. LKY Class II 1989-04-27
K890871 BARD MOSS(R) GASTROSTOMY TUBE C.R. Bard, Inc. KNT Class II 1989-04-27
K890716 LUXTEC ACO SERIES 4000 LIGHT SOURCE Luxtec Corp. FCW Class II 1989-04-26
K892262 FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M Fresenius USA, Inc. KDI Class II 1989-04-25
K884322 SUBCLAVIAN HEMODIALYSIS CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic LFJ Class II 1989-04-25
K892000 FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE Schott Fiber Optics, Inc. FAM Class II 1989-04-25
K890466 SIGMOID TONOMITOR Tonometrics, Inc. GBT Class II 1989-04-21
K882610 COOK-GIANTURCO BILIARY Z STENT Cook, Inc. FGE Class II 1989-04-21
K883782 BELZER UW-CSS Du Pont Critical Care KDL Class II 1989-04-20
K884097 MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES Circon Acmi ODC Class II 1989-04-17
K891921 BICARBONATE CONCENTRATE POWDER Haemolyte, Inc. KPO Class II 1989-04-17
K890029 HEMO-CATH SILICONE DOUBLE LUMEN CATHETER Medical Components, Inc. LFJ Class II 1989-04-17
K891902 CHISELS- FREER, LUCAS, ALEXANDER, BISHOP Zinnanti Surgical Instruments, Inc. KGD Class II 1989-04-12
K890099 MODIFIED VAS-CATH CATHETER REPAIR KIT Vas-Cath, Inc. LFJ Class II 1989-04-11
K891764 FC-101 FEMORAL CATHETER GUIDE WIRE Akcess Medical Products, Inc. LFK Class II 1989-04-07
K891754 DC-4 SHUNT INFUSION T Akcess Medical Products, Inc. FKB Class II 1989-04-07
K891159 SODIUM BICARBONATE, U.S.P. Williams Medical Co. KPO Class II 1989-04-07
K891763 FC-100 FEMORAL CATHETER Akcess Medical Products, Inc. LFK Class II 1989-04-07
K891752 DA-46 FLUID BARRIER Akcess Medical Products, Inc. FIB Class II 1989-04-07
K890116 ENTERAL FEEDING TUBE Hdc Corp. FPD Class II 1989-04-05
K890717 MODIFICATION HEMOFILTRATION CATHETER HF-100 Vas-Cath, Inc. LFK Class II 1989-04-05
K890288 PERITONEAL CATHETERS WITH AN ADDED FUNCTION Quinton, Inc. FJS Class II 1989-03-27
K890436 TECHNOMED PULSOLITH LASER SYSTEM Teknomed, Inc. FFK Class II 1989-03-23
K891254 UROLOGICAL STONE BASKET Northgate Research, Inc. FFL Class II 1989-03-22
K891252 UROLOGICAL LOOP RETRIEVERS Northgate Research, Inc. FGO Class II 1989-03-22
K891253 UROLOGICAL GRASPING FORCEPS Northgate Research, Inc. FGO Class II 1989-03-22
K882746 ADMS SILENT NEEDLE GUN Advanced Diagnostic Medical Systems, Inc. KNW Class II 1989-03-17
K885017 HEMOSORBA CH-500, CH-350 AND CH-180 Asahi Medical Co., Ltd. FLD Class II 1989-03-17
K884857 COLONOSCOPE GUIDING TUBE DEVICE Mill-Rose Laboratory FDF Class II 1989-03-17
K884339 TORAY FILTRYZER DIALYZERS Toray Industries (America), Inc. FJI Class II 1989-03-17
K885092 BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 Medical Imaging Systems, Inc. KPL Class II 1989-03-10
K890203 ADMS BIOPSY NEEDLE Advanced Diagnostic Medical Systems, Inc. FCG Class II 1989-03-08
K890327 BIOPSY NEEDLE GUIDE ATTACHMENT Elscint, Inc. FCG Class II 1989-03-08
K884025 CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200 Circon Acmi KNS Class II 1989-03-03
K885339 FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT Superior Healthcare Group, Inc. KNT Class II 1989-03-01
K890550 CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) Consolidated Products & Services, Inc. KNX Class II 1989-02-28
K884379 MAGLINTE ENTEROCLYSIS CATHETER Lafayette Pharmacal, Inc. FGD Class II 1989-02-28
K890551 URINARY DRAINAGE UNIT Consolidated Products & Services, Inc. KNX Class II 1989-02-28
K884527 ZINETICS(R) EMC Zinetics Medical, Inc. KLA Class II 1989-02-28
K884415 EP-100 (SERIES) Stereotactic Medical Systems, Inc. FPD Class II 1989-02-28
K885169 STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE Boston Scientific Corp KNW Class II 1989-02-27
K883407 TORAY FILTRYZER BK SERIES Toray Industries (America), Inc. KDI Class II 1989-02-27
K890552 CP&S GAVAGE CONSTAINER, DISPOSABLE Consolidated Products & Services, Inc. KNT Class II 1989-02-24
K884819 O'NEIL URINARY CATHETER INTRODUCER Medical Marketing Group KNY Class II 1989-02-17
K885180 EXPANDABLE BILIARY STENT ENDOPROSTHESIS Schneider Intl., Ltd. FGE Class II 1989-02-16
K883189 MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS KARL STORZ Endoscopy-America, Inc. FFK Class II 1989-02-13
K884738 CANDELA STONE BASKETS Candela Laser Corp. FFL Class II 1989-02-09
K884127 LAKE N/G FEEDING TUBE Lake Medical Products, Inc. KNT Class II 1989-02-08
K885323 DACOMED EXTERNAL MALE CONTINENCE DEVICE Dacomed Corp. FHA Class I 1989-02-08

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