meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
43
Latest Decision
1982-10-06

Clearances · page 104 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K822386 COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA Hospal Medical Corp. FII Class II 1982-10-06
K822851 DISSCAP 080 Hospal Medical Corp. FKQ Class II 1982-10-04
K822535 CIDEX*DIALYZER DISINFECTING SOLUTION Surgikos, Inc. FKQ Class II 1982-09-30
K822585 LITHOTRIPTOR ELECTRODE 4.5F Monaghan Medical Corp. FFK Class II 1982-09-28
K822565 NEEDLE CATHETER JEJUNOSTOMY KIT Bio-Research Associates, Inc. KNT Class II 1982-09-28
K822307 ADHESIVE SPRAY #4050-4060 The Healthcare Group Laboratories, Inc. KNX Class II 1982-09-24
K821818 RETRIEVAL BALLOONS American Endoscopy, Inc. KOD Class II 1982-09-24
K822738 TRIEX-IH DIALYZER Extracorporeal Medical Specialities, Inc. KOC Class II 1982-09-24
K822743 SOLID STATE CONTINUOUS FLOW CONTROL Widran Urological Group, Ltd. LJH Class II 1982-09-24
K822686 DENVER PERITONEO-VENOUS SHUNT (DP-VS) Denver Biomedicals, Inc. KPM Class II 1982-09-21
K822644 RIWOLITH 2135 R. Wolf Medical Instruments Corp. FFK Class II 1982-09-21
K822380 ROMBEAU GASTROSTOMY-JEJUNAL TUBE Hedeco KNT Class II 1982-09-17
K822025 AUTOMATIC SPLICING DEVICE E.I. Dupont DE Nemours & Co., Inc. FKX Class II 1982-09-09
K822631 ARGYLE DUO-TUBE Sherwood Medical Co. KNT Class II 1982-09-09
K822228 GASTRO VAGE SET FOR GASTRIC LAVAGE Ackrad Laboratories KNT Class II 1982-09-09
K822547 CAPD BELT American Medical Products, Inc. FKX Class II 1982-09-09
K822244 NEPHROSOL Dialysis Systems, Inc. KOC Class II 1982-09-02
K822443 NASO-GARD NASOGASTRIC TUBE HOLDER American Pharmaseal Div. Ahsc KNT Class II 1982-09-02
K822485 HPF 100,200,300 CAPILLARY FLOW DIALYZ Erika, Inc. FKQ Class II 1982-08-30
K821979 STERILE FOLEY CATHETERIZATION KITS Medical Devices, Inc. KNX Class II 1982-08-30
K822194 ENDOSCOPIC SPONGE CARRIER Kelleher Corp. FGS Class II 1982-08-27
K822401 ST. MARK'S RECTAL BIOPSY FORCEPS Keymed, Inc. KOA Class I 1982-08-27
K822283 TS-000 ARTERIOVENOUS BLOOD TUBING SET Extracorporeal Medical Specialities, Inc. KOC Class II 1982-08-27
K821999 ENDOSCOPIC SCLEROTHERAPY BALLOON Retech GCP Class II 1982-08-27
K821978 STERILE URETHRAL CATHETERIZATION SET Medical Devices, Inc. KNX Class II 1982-08-25
K821819 PIGTAIL STENTS American Endoscopy, Inc. FGE Class II 1982-08-20
K822254 ELECTRIC CORD FOR ENDOSCOPE Kelleher Corp. FFZ Class II 1982-08-20
K822361 DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 Travenol Laboratories, S.A. FKX Class II 1982-08-16
K822226 ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN Erika, Inc. KOC Class II 1982-08-16
K822225 ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE Erika, Inc. KOC Class II 1982-08-16
K822049 LUNDIA 10-5 N PARALLEL FLOW DIALYZER Gambro, Inc. KOC Class II 1982-08-16
K822395 CF 1211 CAPILLARY FLOW DIALYZER CODE Travenol Laboratories, S.A. FJH Class II 1982-08-12
K821825 CONPHAR SILICONE FEEDING TUBE Conphar, Inc. KNT Class II 1982-08-10
K821848 ASSURE-MALE EXTERNAL INCONTINCE CATHETER Medical Design & Manufacturing Corp. KNX Class II 1982-08-10
K821974 PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A Pentax Precision Instrument Corp. FBN Class II 1982-08-10
K821628 THE INFLATABLE PENILE PROSTHESIS American Medical Systems, Inc. FAE Class II 1982-08-10
K821817 PIGTAIL NASAL CATHETERS American Endoscopy, Inc. FGE Class II 1982-08-10
K822134 SHIELY DUEL LUMEN SUBCLAVIAN CANNULA Shiley, Inc. LFJ Class II 1982-08-03
K821829 UROGARD Buckman Consultants KNX Class II 1982-07-30
K821328 C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP Medionics International , Ltd. KPF Class II 1982-07-28
K821001 MCPARLAND SCALP VEIN CATHETER Renal Systems, Inc. LFJ Class II 1982-07-22
K821853 U-100 BAG Medical Technologies of Georgia KNX Class II 1982-07-22
K821854 U-200 BAG Medical Technologies of Georgia KNX Class II 1982-07-22
K821970 DYNACOR URETHRAL CATHETER TRAY Medline Industries, Inc. KOD Class II 1982-07-21
K822061 LAVAGING CATHETERS American Endoscopy, Inc. OCX Class II 1982-07-20
K821955 MCSCK638 CATHETER IN A TRAY (KIT) Medcomp LFJ Class II 1982-07-14
K821954 MCSCK838 CATHETER IN A TRAY (KIT) Medcomp LFJ Class II 1982-07-14
K821939 UROCOMP MODEL 1404 Life-Tech Intl., Inc. FAP Class II 1982-07-13
K821906 CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP Corpak Medsystems KNT Class II 1982-07-13
K820524 CLIRANS HOLLOW FIBER DIALYZERS Terumo Medical Corp. FJI Class II 1982-07-08
K821271 BARD PROTECTIVE BARRIER FILM C.R. Bard, Inc. EXB Class I 1982-07-02
K821834 MODEL 100 BICARBONATE CONDUCTIVITY Western Laboratories Corp. FKQ Class II 1982-07-02
K820546 CARD U.V. GERMICIDAL CHAMBER II Travenol Laboratories, S.A. KDJ Class II 1982-06-30
K821587 ERIKA HPF 50 DIALYZER Erika, Inc. FJI Class II 1982-06-25
K821684 MCSCP8PS WITH 'Y' HUB Medical Components, Inc. LFJ Class II 1982-06-24
K821680 HOLLISTER CATHETER ACCESS. PORT Hollister, Inc. EXB Class I 1982-06-24
K821753 A O FIBER OPTIC ILLUMINATION, 1185A Warner-Lambert Co. FCR Class II 1982-06-24
K821745 BARDEX ALL SILICONE PEDIATRIC CATHETER C.R. Bard, Inc. KOD Class II 1982-06-24
K821754 A O FIBER OPTIC ILLUMINATOR, 1185B Warner-Lambert Co. FCR Class II 1982-06-24
K821268 TRANSDUCER FILTER Cp Medical FIB Class II 1982-06-23
K821383 ECHO, MODEL MM-1000 Mesa Medical, Inc. LIF Class II 1982-06-23
K813432 HEMODIALYSIS SYSTEM Fhk FKP Class II 1982-06-23
K821400 MAHURKAR SUBCLAVIAN CATHETER Quinton, Inc. LFJ Class II 1982-06-23
K820743 HOLLOW FIBER DIALYZERS Terumo Medical Corp. FJI Class II 1982-06-23
K821690 ERIKA HPF 100,200,300 DIALYZER Erika, Inc. FJI Class II 1982-06-22
K821588 SANDHILL DMS Sandhill KLA Class II 1982-06-22
K821272 BN-74 COATED BARDEX ALL SILICONE CATH C.R. Bard, Inc. KOD Class II 1982-06-22
K821496 DISPOSABLE IRRIGA/ASPIR. SYSTEM Innovative Surgical Products, Inc. KDH Class II 1982-06-22
K821313 SURGICAL UTILITY DRAPE Megaplast, Inc. FJZ Class II 1982-06-21
K821666 STERILE SURGICAL DRAPES Phoenix Glove Co. FJZ Class II 1982-06-21
K821546 MONITORING DEVICE ENURESIS ALARM & ACC. Wetbell, Inc. KPN Class II 1982-06-09
K821012 H-H ALIMENTATION CATHETERS Holter-Hausner Intl. LFJ Class II 1982-05-28
K821367 GF-180-M & GF-180-H HEMODIALYZERS Gambro, Inc. KOC Class II 1982-05-28
K821495 DISPOSABLE BLOOD LINE CONNECTORS Bentley Laboratories, Inc. KOC Class II 1982-05-27
K821415 MODEL 90 BC Western Laboratories Corp. FLB Class II 1982-05-27
K821409 CORPAK-ENTERAL FEEDING CONTAINER Corpak Co. KNT Class II 1982-05-24
K821397 ADULT INCONTINET BRIEF Johnson & Johnson Professionals, Inc. EYQ Class I 1982-05-24
K821410 CORPAK-MONITOR ENTERAL FEEDING CONTAIN Corpak Co. KNT Class II 1982-05-24
K821168 DISPOSABLE URINARY LEGBAG W/STRAP Medical Marketing Group KNX Class II 1982-05-24
K820909 GORE-TEX PERITONEAL CATHETERR W. L. Gore & Associates, Inc. FJS Class II 1982-05-21
K821336 TRANSENDOSCOPIC INJECTION CATHETER TEI Sounson Research Co., Inc. KNY Class II 1982-05-21
K820575 J.E.T. DIALYSIS SYSTEM Computer Dialysis Systems, Inc. FKJ Class II 1982-05-20
K821304 CENTRALYTE BICARBONATE CONCENTRATE Erika, Inc. KPO Class II 1982-05-18
K820987 FOLEY INSERTION TRAYS W/OVERWRAY Inmed Corp. KOD Class II 1982-05-13
K820851 CURITY ECONOMY II CYSTOSCOPY TRAY The Kendal Co. FAJ Class II 1982-05-13
K820838 CURITY ECONOMY I CYSTOSCOPY The Kendal Co. KOD Class II 1982-05-11
K821138 TS-180 SERIES TUBING SET Extracorporeal Medical Specialities, Inc. FJK Class II 1982-05-10
K821161 EXTERNAL URINARY MALE INCONTINENCE DEV The Healthcare Group Laboratories, Inc. KNX Class II 1982-05-10
K821139 SPS-SINGLE PATIENT SYSTEM Extracorporeal Medical Specialities, Inc. FIR Class II 1982-05-10
K821171 URINARY COLLECTION CONTAINER/LEG BAG The Healthcare Group Laboratories, Inc. KNX Class II 1982-05-10
K821231 VIVONEX TUNGSTEN TIP TUBE PLACEMENT Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1982-05-10
K821172 EXTERNAL FEMALE URINARY INCONTINENCE The Healthcare Group Laboratories, Inc. KNX Class II 1982-05-10
K821067 VIVONEX ACUTROL ENTERNAL FEEDING SYS Norwich Eaton Pharmaceuticals, Inc. KNT Class II 1982-04-29
K820695 AUTOMATIC DIALYZER REPROCESSOR #ADR-22 Texas Medical Devices, Inc. LIF Class II 1982-04-29
K821036 ENTERNAL SOLUTION ADMIN. SET Corpak Co. KNT Class II 1982-04-26
K820868 URETERAL CATHETER CONNECTOR Van-Tec, Inc. KOD Class II 1982-04-26
K820870 URETERAL STANT SET Van-Tec, Inc. FAD Class II 1982-04-26
K820866 URETERAL CATHETER CONNECTING TUBE Van-Tec, Inc. KOD Class II 1982-04-26
K820966 DISSCAP 110 Hospal Medical Corp. FKQ Class II 1982-04-16
K820769 GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL Gambro, Inc. FKQ Class II 1982-04-16

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