meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
61
Latest Decision
1977-11-30

Clearances · page 112 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K771875 ULTRAFILTRATION MONITOR 5M9034 Travenol Laboratories, S.A. FIL Class II 1977-11-30
K772148 CATHETER, FEMORAL VEIN, SF 6 Sorensen Research FJT Class II 1977-11-29
K772146 CATHETER, VEIN, FEMORAL, SF 10 Sorensen Research FJT Class II 1977-11-29
K771483 CATHETER FINGER GRIP Quinton, Inc. FJS Class II 1977-11-28
K772133 URINE SPECIMEN COLLECTING DEVICE Kendall Research Center FCN Class II 1977-11-28
K772144 CATHETER, DISP., EXTERNAL, MALE Medline Industries, Inc. EXJ Class I 1977-11-28
K772163 DIALYSIS MACHINES DM-346 & 346-1 Extracorporeal Medical Specialities, Inc. FIJ Class II 1977-11-28
K771555 PERITONEAL DIALYSIS CATHETER Fluoro-Mold Co. FJS Class II 1977-11-28
K772134 SYRINGE, IRRIGATION, PRE-FILLED Kendall Research Center KOA Class I 1977-11-28
K772040 TRANSDUCER PROTECTOR Terumo America, Inc. FKJ Class II 1977-11-28
K772150 DIALYSIS DRAINAGE UNIT, PERITONEAL C.R. Bard, Inc. FKX Class II 1977-11-28
K771420 BETA-CAP Quinton, Inc. FJS Class II 1977-11-28
K772147 GW 35 GUIDE WIRE Sorensen Research FIF Class II 1977-11-28
K771864 WALL TRANSFORMERS 74710 & 74910 Welch Allyn, Inc. GCW Class II 1977-11-22
K771265 PRESSURE MONITOR MANOMETRIC SYS. Physio-Control Corp. KLA Class II 1977-11-22
K771723 HILL TUBE Physio-Control Corp. KLA Class II 1977-11-22
K772113 URINARY DRAINAGE BAG 2D9017 Travenol Laboratories, S.A. EYZ Class I 1977-11-16
K771986 CATHETER, MEDIASTINAL&PERICARDIAL The Minnesota Back Brace Co. FHF Class II 1977-10-28
K771484 RINSE BLOCK ASSEM, D-W PERI. DIALYSIS Quinton, Inc. FKX Class II 1977-10-25
K771421 CATHETEO CLAMP Quinton, Inc. FFN Class I 1977-10-25
K771792 ENEMA SET Chase Mfg. Co. FCE Class I 1977-10-20
K771918 FIBEO OPTICS ILLUM. SYSTEM Propper Mfg. Co., Inc. GCP Class II 1977-10-20
K771919 FIBER OPTICS SIGMOIDOSCOPE Propper Mfg. Co., Inc. GCP Class II 1977-10-20
K771920 FIBER OPTICS PROCTOSCOPE Propper Mfg. Co., Inc. GCP Class II 1977-10-20
K771428 TENCKHOFF PERITONEAL TUBING ADAPT. Quinton, Inc. FKY Class II 1977-10-18
K771860 FOLHY CATHETER Polysil, Inc. EZL Class II 1977-10-18
K770789 URI-DRAIN COMBO KIT FOR MALE INCONTINENC Chesebrough-Pond'S U.S.A. Co. KNX Class II 1977-10-18
K770814 CATHETER, URETHERAL C.R. Bard, Inc. KOD Class II 1977-10-18
K771850 UROFLOW-CYSTOMETER SYSTEM Richard Wolf Medical Instruments Corp. FAP Class II 1977-10-18
K770943 ENDOSCOPE, UROLOGICAL, FEMALE C.R. Bard, Inc. FAL Class II 1977-10-18
K771655 CURITY PEAKOMETER Kendall Research Center FFG Class II 1977-10-14
K771815 SIGMOSCOPE Dynatech Cryomedical Co. FAM Class II 1977-10-07
K771779 CATHETERIZATION SYS. URINARY DRAINAGE Medical Devices, Inc. KOD Class II 1977-10-05
K771763 HEMO-RO Millipore Corp. FIP Class II 1977-10-04
K770857 DIALYSIS MACHINE, CENTRY II Cobe Laboratories, Inc. FJF Class II 1977-10-04
K771859 NEEDLE HOLDER, MICROVASCULAR Edward Weck, Inc. FHQ Class I 1977-10-04
K771705 RS-7800 MINIPUMP Renal Systems, Inc. FIR Class II 1977-10-04
K771775 COLORPLAST TRANSVERSE SYSTEM C.R. Bard, Inc. EXB Class I 1977-09-30
K771739 PENTAX LH-150F LIGHT SOURCE Pilling Co. FCW Class II 1977-09-30
K771725 BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. Xomed, Inc. FEX Class I 1977-09-26
K771651 AKRO-SIL FOLEY KIT 5CC Latex Ind., Inc. FCM Class II 1977-09-20
K771435 URINARY LEG BAG, STEOILE Meddev International Corp. KNX Class II 1977-09-20
K771650 AKRO-SIL FOLEY KIT 30CC Latex Ind., Inc. FCM Class II 1977-09-20
K771693 CLIRANS BLOOD LINES SET Terumo America, Inc. FJK Class II 1977-09-20
K771652 CATH-CARE TRAY Latex Ind., Inc. FCM Class II 1977-09-20
K771375 PRESSURE MODULE 5M1247 Travenol Laboratories, S.A. FKQ Class II 1977-09-15
K771694 CLIRANS TH 15 HOLLOW FIBER DIALYZER Terumo America, Inc. FJI Class II 1977-09-15
K771696 EMODIALYSIS DEL. SYS. MODEL 7110 Bd Becton Dickinson Vacutainer Systems Preanalytic FKP Class II 1977-09-15
K771354 PARALLEL PLATE DIALYZERS Hospal Medical Corp. FJG Class II 1977-09-15
K771212 SAFEED DISP. PLASTIC CATHETER Terumo America, Inc. KNY Class II 1977-09-12
K771561 DOVER URINE METER Will Ross Co. EXR Class II 1977-09-07
K771419 CANNULA CLAMP Quinton, Inc. FKC Class I 1977-08-26
K771424 TUBE OCCLUDING FORCEPS Quinton, Inc. KOC Class II 1977-08-26
K770966 INTERNAL ECOLOGY MACHINE Holistic Equipment, Inc. KPL Class II 1977-08-18
K771495 A.V. FISTULA NEEDLE SET (#361) Sorensen Research FIE Class II 1977-08-16
K771493 A.V. FISTULA NEEDLE SET (#341) Sorensen Research FIE Class II 1977-08-16
K771491 A.V. FISTULA NEEDLE SET (#364) Sorensen Research FIE Class II 1977-08-16
K771494 A.V. FISTULA NEEDLE SET (354) Sorensen Research FIE Class II 1977-08-16
K771490 A.V. FISTULA NEEDLE SET (#344) Sorensen Research FIE Class II 1977-08-16
K771492 A.V. FISTULA NEEDLE SET (#351) Sorensen Research FIE Class II 1977-08-16
K771368 PORTABLE INFANT VENTILATOR Cavitron Corp. FOC Class II 1977-08-04
K771302 PFISTER-SCHWARTZ STONE RETRIEVER V. Mueller O.V. Baxter Healthcare Corp. FGO Class II 1977-08-02
K771367 CHOLEDOCHOSCOPE SYSTEM Richard Wolf Medical Instruments Corp. FBN Class II 1977-08-02
K771364 LUBE JEL Travenol Laboratories, S.A. FHX Class II 1977-08-02
K771227 AK-10 Gambro, Inc. FIL Class II 1977-08-02
K771349 MODIFICATION TO KIDNEY DIALYZER Erika, Inc. FHS Class II 1977-08-02
K771108 NEEDLE, CHIBA UNIVERSITY Johannah Medical Services, Inc. FCG Class II 1977-07-29
K771048 CATHETERS, DRAINAGE Axiom Medical, Inc. FEG Class II 1977-07-19
K770982 UNITED SKIN BARRIER Howmedica Corp. EXE Class I 1977-07-15
K771206 AV FISTULA NEEDLE SET Terumo America, Inc. FIE Class II 1977-07-15
K771210 UROGARD URINARY DRAINAGE BAG Terumo America, Inc. FCN Class II 1977-07-11
K771066 CATHETER, SAMPLING, CONDUIT Mentor Corp. FEZ Class II 1977-07-11
K770826 POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE Howmedica Corp. FON Class I 1977-06-28
K771065 DYLADE, MODEL DS Milton Roy Co. Analytical FKP Class II 1977-06-24
K770864 HEMODIALYSIS FISTULA SET Venospital, Inc. FIE Class II 1977-06-24
K771104 URETHRAL TRAY W/OUT CAHTETER, 7650 Concord Laboratories, Inc. FCM Class II 1977-06-24
K771103 URETHRAL TRAY W/CATHETER, 7750 Concord Laboratories, Inc. FCM Class II 1977-06-24
K770867 DIALYZER, FIBER, HOLLOW Cobe Laboratories, Inc. FJI Class II 1977-06-14
K770699 NEEDLE SET, A-V FISTULA Medical Disposables Intl., Inc. FIE Class II 1977-06-14
K770858 DIALYZER, ULTRADIFFUSER, DISPOSABLE Gambro, Inc. FJG Class II 1977-06-14
K770897 URODYNAMIC INSTRUMENTS Life-Tech Instruments, Inc. EXY Class II 1977-06-03
K770423 URINE TESTER, MODEL NO. 707 Brother Scientific Products, Inc. EXR Class II 1977-06-03
K770939 URINE TESTER, MODEL 701 Brother Scientific Products, Inc. EXR Class II 1977-06-03
K770906 ANOSCOPE, OPTIC, FIBER Welch Allyn, Inc. FER Class II 1977-06-01
K770913 UROLOGICAL BIOPSY BRUSH SET Cook, Inc. FDX Class II 1977-06-01
K770579 CATHETER, URETHRAL PRESSURE, UPE-10 & 12 Life-Tech Instruments, Inc. FAP Class II 1977-05-23
K770785 MONITOR, RESPIRATORY, TWO-GAS, RDC Research Development Corp. KLA Class II 1977-05-20
K770734 DIALYZER, FIBER, HOLLOW Travenol Laboratories, S.A. FJI Class II 1977-05-10
K770735 DIALYZER, COIL, CD, LSA, 5M1765 Travenol Laboratories, S.A. FHS Class II 1977-05-10
K770762 BAG, URINARY, DRAINAGE, 2D9013 Travenol Laboratories, S.A. KNX Class II 1977-05-10
K770620 TUBING FEEDING KIT Doyle Pharmaceutical FPD Class II 1977-05-03
K770729 PYELOSCOPE SYSTEM Richard Wolf Medical Instruments Corp. FGA Class II 1977-04-28
K770691 GAMBRO VENOUS BLOOD LINE Gambro, Inc. KOC Class II 1977-04-28
K770712 TROCAR SLEEVE SYSTEM 4MM TO 3.4MM Richard Wolf Medical Instruments Corp. GCJ Class II 1977-04-26
K770711 TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM Richard Wolf Medical Instruments Corp. GCJ Class II 1977-04-26
K770535 C-DAK 3500 Cordis Corp. FIG Class II 1977-04-15
K770672 COLLECTOR, SANI-CATCH, NO. 1010 Concord Laboratories, Inc. KNX Class II 1977-04-15
K770578 PARALLEL PLATE DIALYZER Cobe Laboratories, Inc. FJG Class II 1977-04-15
K770439 STOMA BAG W/SKIN BARRIER SEAL RING Hollister, Inc. EXB Class I 1977-04-15
K770673 COLLECTOR, SANI-CATCH, NO. 1014 Concord Laboratories, Inc. KNX Class II 1977-04-15

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