meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
55
Latest Decision
1978-12-12

Clearances · page 111 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K781748 IRRIGATION TRAY Intermed, Inc. EYN Class II 1978-12-12
K781641 SURGITEK DOUBLE J URETEROL STENT Medical Engineering Corp. FAD Class II 1978-12-07
K781967 HEMODIALYSIS CONCENTRATE, SODIU Renal Systems, Inc. KPO Class II 1978-12-07
K781633 ULTRAFILTRATION SCALE Extracorporeal Medical Specialities, Inc. FIL Class II 1978-12-07
K781405 SUITCASE KIDNEY HEMODIALYSIS SYSTEM Union Carbide Corp. FKP Class II 1978-12-07
K781780 CATHETER, EXTERNAL MALE NURSING CARE Medi-Tech, Inc. KNX Class II 1978-12-07
K781749 TUBING, AXIOM SILICONE PENROSE Axiom Medical, Inc. KDH Class II 1978-12-04
K781987 URINARY DRAINAGE BAG Kelsar Corp. KNY Class II 1978-12-04
K781521 CUTTER RESIFLEX URINE METER Cutter Laboratories, Inc. KNX Class II 1978-11-22
K781736 DISC, COLOPLAST PRE-OP STOMA C.R. Bard, Inc. EXA Class I 1978-11-03
K781433 AKRON MALE EXTERNAL CATHETER Latex Ind., Inc. KNX Class II 1978-11-03
K781333 CENTRAL CATHETER TRAY Argon Medical Corp. KGC Class II 1978-10-24
K781102 DIALYZER, DISP., COIL, LUNDIA Gambro, Inc. FHS Class II 1978-10-17
K781353 PAPILLOTOME CUTTING SNARE Cameron-Miller, Inc. KNS Class II 1978-10-10
K781303 BIO-PRO UNIT Bd Becton Dickinson Vacutainer Systems Preanalytic FKR Class II 1978-10-02
K781597 PM 2000 AUTOMATIC PATIENT CHAIR Time Motion System Co. FFG Class II 1978-09-27
K781050 DLC 500, DOUBLE LUMEN CATHETER Hemodialysis, Division of The KOC Class II 1978-09-26
K781457 FOLEY CATHETERS Intermed, Inc. KOD Class II 1978-09-20
K781375 COMFORM ABSORBANT INCONTINENCE PADS Kimberly-Clark Corp. EYQ Class I 1978-09-20
K781373 OSTOMY APPLIANCE W/DEODORIZING FILTER Hollister, Inc. EXB Class I 1978-09-20
K781142 DISSCAP Hospal Medical Corp. FJI Class II 1978-09-14
K781385 DOBBHOFF ENTERIC FEEDING BAG Biosearch Medical Products, Inc. FPD Class II 1978-09-07
K781422 KWIK-FLO URINAL SYSTEM The Grace Mfg. Co. KNX Class II 1978-09-07
K781230 GAVAGE ADMIN. SET Mcgaw Laboratories KNT Class II 1978-09-07
K781176 PATIENT AID, MODEL DM-351 Extracorporeal Medical Specialities, Inc. FKQ Class II 1978-09-07
K780932 MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT Western Laboratories Corp. FIZ Class II 1978-08-31
K760897 STERILE URETHRAL CATHETER KIT Diamed Division Ill. Tool Works, Inc. KOD Class II 1978-08-31
K781330 BLOOD LEVEL DETECTOR-MODEL 7601 Bd Becton Dickinson Vacutainer Systems Preanalytic FJF Class II 1978-08-31
K781058 C-DAK 4000 ARTIFICIAL KIDNEY Cordis Corp. FJI Class II 1978-08-23
K781088 OSTOMY APPLIANCE BELT E. R. Squibb & Sons, Inc. EXB Class I 1978-08-18
K781011 K-Z CONCENTRATE K-Zyme Labs, Inc. EXB Class I 1978-08-17
K780877 ENEMA BAG Abco Dealers, Inc. FCE Class I 1978-08-14
K781038 HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM Quinton, Inc. KNW Class II 1978-08-14
K780879 URETHRO CATHETERIZATION TRAY Abco Dealers, Inc. FCM Class II 1978-07-31
K780878 LEG BAG Abco Dealers, Inc. KNX Class II 1978-07-31
K780660 NITE TRAIN'R Nite Train-R Enterprises, Inc. KPN Class II 1978-07-28
K780831 URINARY CATHETERIZATION SYSTEM W/O FOLEY Medical Devices, Inc. KNX Class II 1978-07-27
K780837 URINARY DRAINAGE BAG Intermed, Inc. KNX Class II 1978-07-27
K780774 PAPILLOTOMY KNIVES Olympus Corp. KNS Class II 1978-07-27
K780700 LUNDIA PLATE DISPOSABLE DIALYZER Gambro, Inc. FJG Class II 1978-07-17
K780765 PERCUTANEOUS SURAPUBIC CATHETER Vance Products, Inc. KOB Class II 1978-07-17
K780484 SILASTIC BRAND PENILE IMPLANT Dow Corning Corp. Healthcare Industries Materials FIQ Class II 1978-07-17
K780957 SET, ADMINISTRATION, MANUAL, DIALYSIS American Medical Products, Inc. KDJ Class II 1978-07-06
K780582 DETECTOR, BUBBLE & FOAM Hospal Medical Corp. FJF Class II 1978-06-22
K780682 SINGLE PATIENT SYSTEMS Extracorporeal Medical Specialities, Inc. FKP Class II 1978-06-22
K780681 ARTERIOVENOUS BLOOD TUBING SETS Extracorporeal Medical Specialities, Inc. FJK Class II 1978-06-14
K780735 URINARY CATHETER CARE SET Shield Laboratories, Inc. FCM Class II 1978-06-13
K780812 ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330 Honeywell, Inc. FFX Class II 1978-06-13
K780613 ENEMA, PHOSPHATE Abco Dealers, Inc. FCE Class I 1978-06-02
K780471 GASTRIC LAVAGE KIT Gaymar Industries, Inc. FAT Class II 1978-06-02
K780427 RP-510/RP-514 PARALLEL PLATE DIALYZERS Hospal Medical Corp. FJG Class II 1978-05-19
K780473 ILEX STOMA SEAL AND PROTECTIVE CREAM Virgil Pichierri EXB Class I 1978-05-16
K780449 BETA CAP SYSTEM Quinton, Inc. FJS Class II 1978-05-16
K780676 STERILE CLOSED SYSTEM Medline Industries, Inc. KOD Class II 1978-05-09
K780675 STERILE 100% SILICONE FOLEY CATHETER Medline Industries, Inc. KOD Class II 1978-05-09
K780410 BLOOD PUMP-MODE S10K 3M Health Care, Sarns FIR Class II 1978-05-03
K780137 CLAMP, INCONTINENCE, BAUMRUCKER Greenwald Surgical Co., Inc. FHA Class I 1978-04-28
K780470 H.P. MEDICAL GRADE SILICONE TUBING Dow Corning Corp. Healthcare Industries Materials KDL Class II 1978-04-27
K780643 SHADOW-CATHS Quinton, Inc. FJS Class II 1978-04-27
K780409 COLOPLAST-DURASEAL OSTOMY APPLIANCE C.R. Bard, Inc. EZS Class I 1978-04-27
K780454 ACTIVE-LIFE E. R. Squibb & Sons, Inc. EXB Class I 1978-04-21
K770534 THERAPEUTIC APPARATUS, DIERKER TYPE Well Being Ent. KDH Class II 1978-04-21
K780511 SNAP-FIT E. R. Squibb & Sons, Inc. EXB Class I 1978-04-21
K780411 TAYLOR CATHETER HOLDER Taylor Catheter Holder Mfg. EZD Class II 1978-04-13
K780386 K-Y LUBRICATING JELLY Johnson & Johnson Professionals, Inc. FHX Class II 1978-04-13
K780415 VIVONEX DELIVERY SYSTEM Norwich Pharmacal Co. FPD Class II 1978-04-10
K780353 DRI-LYTE Mallinckrodt Critical Care KPO Class II 1978-04-05
K780081 DIALYZING FLUIDE DELIVERY SYSTEM Travenol Laboratories, S.A. FKQ Class II 1978-03-31
K772362 AVF SET FOR SINGLE NEEDLE HEMODIALYSIS Terumo America, Inc. FIE Class II 1978-03-17
K772290 DIALYZER, CAPILATORY, HOLLOW FIBER Redy Laboratories FJI Class II 1978-03-15
K772282 HODGE TUBE Mallinckrodt Critical Care FEG Class II 1978-03-09
K772277 BLADDER RETENTION-CATHETHERIZATIONTRAY Latex Ind., Inc. FCM Class II 1978-03-02
K772340 CATHETERIZATION KIT 732016-732018 Latex Ind., Inc. FCM Class II 1978-02-24
K772342 ROBINSON KIT - 750014 & 750016 Latex Ind., Inc. FCM Class II 1978-02-24
K772341 BLADDER KIT - 734000 Latex Ind., Inc. FCM Class II 1978-02-24
K780267 CATH TRAY W/OUT CATHETER Latex Ind., Inc. EYZ Class I 1978-02-24
K780268 BLADDER CATH KIT W/OUT CATHETER Latex Ind., Inc. FCM Class II 1978-02-24
K780124 CATHETERIZATION PROCED. TRAY, URETHRAL Walpak Co. FCM Class II 1978-02-21
K780123 CATHETERIZATION PROCEDURE TRAY Walpak Co. FCM Class II 1978-02-21
K780190 CATHETER STRAP & RUINARY BAY HOLDER Baka Manufacturing Co., Inc. FAQ Class I 1978-02-21
K780062 CATHETER/HEMOSTATIC/GERIATRIC Kendall Research Center EZL Class II 1978-02-14
K780134 URINARY DRAINAGE MONITORING SYSTEM Medical Devices, Inc. FCN Class II 1978-02-02
K772405 TUBING CLAMP Fred Sammons, Inc. FFN Class I 1978-01-26
K772423 SPIRAFLOW DIALYZERS Bentley Laboratories, Inc. FJI Class II 1978-01-26
K772318 DIALYZER STANDARD, CODE 5DM1780 Travenol Laboratories, S.A. FJG Class II 1978-01-26
K772355 BLOOD LINE COMP. NEG. PRESS. PILLOW Cordis Corp. FIW Class II 1978-01-26
K772402 QUADRIPLEGIC URINARY DRAINAGE VALVE Fred Sammons, Inc. FAQ Class I 1978-01-26
K772366 BAG, DRAINAGEW/ADHESIVE; PROSTHESIS Atlantic Surgical FON Class I 1978-01-26
K772236 FILTER, PERITONEAL DIALY. ADMIN. SET Millipore Corp. KDJ Class II 1978-01-24
K780082 PERITONEAL DIALYSIS ADMIN. SET Physio-Control Corp. KDJ Class II 1978-01-24
K780032 URINARY LEG BAG C.R. Bard, Inc. FAQ Class I 1978-01-17
K771422 PATIENT BY-PASS Quinton, Inc. FJQ Class I 1978-01-03
K772161 HEMODIALYSIS APPARATUS Heald Manufacturing, Inc. FKQ Class II 1978-01-03
K771425 A-V SHUNT EXTENSION Quinton, Inc. FKN Class II 1978-01-03
K771482 RINSE BLOCK CONNECTOR Quinton, Inc. KDJ Class II 1978-01-03
K771429 DISP. TEFLON CONNHCTOR Quinton, Inc. FJQ Class I 1977-12-22
K771426 PEDIATRIC INFUSION T Quinton, Inc. FKB Class II 1977-12-20
K772136 PERITONEAL CYCLER & MANIFOLD SET Physio-Control Corp. KDJ Class II 1977-12-20
K772292 T-TUBE WHELAN-MOSS Davol, Inc. GCA Class II 1977-12-20
K772218 CATHETER, SILICONE COATED Concord Laboratories, Inc. EZL Class II 1977-12-13

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