Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 44
- Latest Decision
- 1979-10-26
Clearances · page 110 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K791992 | DYNACOR STERILE CARELON SILICONE CATH. | Medline Industries, Inc. | KOD | Class II | 1979-10-26 |
| K791489 | VITAL CATHETER | Hospal Medical Corp. | FIE | Class II | 1979-10-26 |
| K791699 | HYDRADJUST II UROLOGICAL TABLE | Sybron Corp. | KQS | Class I | 1979-10-22 |
| K791534 | HOLLISTER UROSTOMY POUCH | Hollister, Inc. | EXB | Class I | 1979-10-09 |
| K791164 | NEGATOVE PRESSURE CONVERTOR | Medicorp, Inc. | FLC | Class II | 1979-10-04 |
| K791645 | VICKERS MEDICAL MODEL 112 TREONIC DC2 | Vickers America Medical Corp. | FKW | Class II | 1979-10-02 |
| K791581 | COLOPLAST CARBON GAS FILTER | C.R. Bard, Inc. | EXB | Class I | 1979-10-02 |
| K791863 | MAC LEE ENEMAD | Mac Lee Medical Products | FCE | Class I | 1979-10-02 |
| K791668 | ENDOSCOPIC CYTOLOGY BRUSHES | Mill-Rose Laboratory | FDX | Class II | 1979-10-01 |
| K791635 | AO TEACHING ATTACHMENT, MODEL TA-1 | American Optical Corp. | FEA | Class I | 1979-09-24 |
| K791321 | ERIKA HPF 200 | Erika, Inc. | FJI | Class II | 1979-09-24 |
| K791322 | ERIKA HPF 300 | Erika, Inc. | FJI | Class II | 1979-09-24 |
| K791320 | ERIKA HPF 100 | Erika, Inc. | FJI | Class II | 1979-09-24 |
| K791717 | BARD URODYNAMIC CATHETERS | C.R. Bard, Inc. | KOD | Class II | 1979-09-17 |
| K791531 | FLEXIFLO ENTERAL PUMP SET | Abbott Laboratories | BSS | Class II | 1979-09-12 |
| K791252 | CONPHAR FEMALE CATHETER W/BAG-STERILE | Conphar, Inc. | KNX | Class II | 1979-09-07 |
| K790894 | URITRON URINE METER | Joseph F. Daniel, C.R.N.A. | FFG | Class II | 1979-09-07 |
| K791244 | CONPHAR FEMALE CATHETER-STERILE | Conphar, Inc. | KOD | Class II | 1979-09-07 |
| K791265 | CONPHAR URINARY DRAINAGE BAG-2000ML | Conphar, Inc. | KNX | Class II | 1979-09-07 |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | Intermed, Inc. | KOD | Class II | 1979-09-07 |
| K790827 | RP-610 PARALLEL PLATE DIALYZER | Hospal Medical Corp. | KDI | Class II | 1979-09-04 |
| K791426 | PERITONEAL PAC | Intermed, Inc. | KDJ | Class II | 1979-08-28 |
| K791448 | HEMODIALYZERS RP-510 AND RP-514 | Hospal Medical Corp. | FJG | Class II | 1979-08-07 |
| K791306 | ELLIK EVACUATOR | Davol, Inc. | KQT | Class II | 1979-08-03 |
| K781923 | NON-RETENTION ENEMA SYSTEM | Hudson Kendale Assoc., Inc. | KPL | Class II | 1979-08-03 |
| K791308 | ULDALL SUBCLAVIAN CANNULA SC-100 | Vas-Cath of Canada , Ltd. | FIQ | Class II | 1979-08-03 |
| K791264 | CONPHAR NELATON CATHETER-STERILE | Conphar, Inc. | KOD | Class II | 1979-08-03 |
| K791257 | CONPHAR FEEDING TUBE-STERILE | Conphar, Inc. | KNT | Class II | 1979-08-03 |
| K791251 | CONPHAR LEG BAG-STERILE | Conphar, Inc. | KNX | Class II | 1979-08-03 |
| K791270 | CONPHAR LEG BAG | Conphar, Inc. | KNX | Class II | 1979-08-03 |
| K791269 | CONPHAR STOMACH TUBE-STERILE | Conphar, Inc. | KNT | Class II | 1979-08-03 |
| K791268 | CONPHAR RECTAL TUBE-STERILE | Conphar, Inc. | KNT | Class II | 1979-08-03 |
| K791262 | CONPHAR URINARY DRAINAGE BAG 2000ML | Conphar, Inc. | KNX | Class II | 1979-08-03 |
| K791250 | CONPHAR STOMACH TUBE-STERILE-X-RAY | Conphar, Inc. | KNT | Class II | 1979-08-03 |
| K791332 | UNIVERSAL FOLEY CATHETER TRAY | Abco Dealers, Inc. | KOD | Class II | 1979-08-03 |
| K791245 | CONPHAR EXTERNAL CATHETER | Conphar, Inc. | KNX | Class II | 1979-08-03 |
| K790922 | DISPOSABLE ADULT DIAPER | Fibre Formations, Inc. | EYQ | Class I | 1979-07-30 |
| K791198 | BIBAG | Ab Medett Produkter | KNX | Class II | 1979-07-30 |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | American Cystocope Makers, Inc. | FGA | Class II | 1979-07-30 |
| K791146 | COLO-TAPE | Suburban Ostomy Supply Co., Inc. | EZR | Class I | 1979-07-30 |
| K791196 | URIDROP | Ab Medett Produkter | KNX | Class II | 1979-07-30 |
| K791086 | CENTRY 2 SYSTEM #016, 103, 016, 104 | Cobe Laboratories, Inc. | FIP | Class II | 1979-07-03 |
| K790841 | TG 2, TRI-GARD PRESSURE MONITOR | Sorensen Research | KOC | Class II | 1979-06-27 |
| K791020 | FLUID ADMINISTRATION SET FA-3160 | Burron Medical Products, Inc. | EYN | Class II | 1979-06-27 |
| K790969 | ARGYLE URINE METER | Sherwood Medical Co. | KNX | Class II | 1979-06-27 |
| K790824 | REPGREEN ULTRAFILTRATION MONITOR | Cyberex Corp. | FIL | Class II | 1979-06-27 |
| K790696 | RDI-1 HOLLOW FIBER DIALYZER | Renal Devices, Inc. | FJI | Class II | 1979-06-20 |
| K790535 | CLAYTON COLON CLEANSING KIT | Clayton Medical Products, Inc. | FCE | Class I | 1979-06-07 |
| K790728 | TOUCHLESS TM FOLEY CATHETER KIT | Diamed Division Ill. Tool Works, Inc. | KOD | Class II | 1979-06-01 |
| K790754 | BROWNE MODEL CF-1 AND CF-1G | Browne Corp. | FAP | Class II | 1979-06-01 |
| K790478 | BROWNE MODEL UD-4DE | Browne Corp. | FAP | Class II | 1979-06-01 |
| K790856 | PROCTOSCOPE #501 | C. Intl. | GCF | Class II | 1979-05-29 |
| K790749 | COLOSTOMY ENEMA DEVICE | Vabar Corp. | EXD | Class II | 1979-05-16 |
| K790519 | ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 | American Medical Systems, Inc. | FAP | Class II | 1979-05-14 |
| K790750 | COLOSTOMY DEVICE W/ PRESSURE LID | Vabar Corp. | EXD | Class II | 1979-05-14 |
| K790607 | GREENLINE IRRIGATION TRAYS | Snyder Laboratories, Inc. | EYN | Class II | 1979-05-11 |
| K790612 | NUTRIFLOW NASOGASTRIC FEEDING TUBE | Biosearch Medical Products, Inc. | KNT | Class II | 1979-05-11 |
| K790365 | FLUID MEASUREMENT STAND | Hewlett-Packard Co. | FFG | Class II | 1979-05-11 |
| K790758 | HEMOCLEAR U-NEPHROS 1.0 DIALYZER | Medical, Inc. | FJG | Class II | 1979-05-08 |
| K790533 | HD CAPILLARY FILM DIALYZER, MODEL 1001 | Travenol Laboratories, S.A. | FJG | Class II | 1979-05-02 |
| K790382 | COIL DIALYSIS, MODELS DM-360 AND DM-360- | Estracorporeal, Inc. | FKD | Class II | 1979-05-02 |
| K790591 | HEMODIALYSIS BLOOD CIRCUIT | Travenol Laboratories, S.A. | KOC | Class II | 1979-05-02 |
| K790308 | DISPOSABLE DIALYZERS, SD-ID, SD-2D | Bentley Laboratories, Inc. | FJI | Class II | 1979-05-01 |
| K790663 | MODEL 1750 STANDING URINAL | Life-Tech Instruments, Inc. | FFG | Class II | 1979-04-24 |
| K790610 | SIGMOIDOSCOPE TIPLESS | Welch Allyn, Inc. | FAM | Class II | 1979-04-23 |
| K790353 | ACUTE RENAL DIALYSIS TRAY | Argon Medical Corp. | FKG | Class I | 1979-04-20 |
| K790381 | ARTERIOVENOUS SETS | Extracorporeal Medical Specialities, Inc. | KOC | Class II | 1979-04-20 |
| K790340 | DELTA-ROL | Johnson & Johnson Professionals, Inc. | GCO | Class II | 1979-04-12 |
| K790253 | URINARY DRAINAGE BAG | Snyder Laboratories, Inc. | KNX | Class II | 1979-04-10 |
| K790254 | FOLEY CATHETERIZATION TRAY | Snyder Laboratories, Inc. | FCM | Class II | 1979-04-10 |
| K790067 | FLOW DIALYZER, CF 2300 CAPILLARY | Travenol Laboratories, S.A. | FJI | Class II | 1979-04-10 |
| K790387 | FEEDING TUBE W/ LUBRICANT COATING | Biosearch Medical Products, Inc. | KNT | Class II | 1979-04-04 |
| K790338 | COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER | American Optical Corp. | FDF | Class II | 1979-04-04 |
| K790071 | ENDOSCOPE AND ACCESSORIES | Olympus Corp. | GCP | Class II | 1979-04-02 |
| K790223 | DIALYZER, CD-800 COIL | Travenol Laboratories, S.A. | FHS | Class II | 1979-03-26 |
| K782021 | A.V. FISTULA NEEDLE SET | Cordis Corp. | FIE | Class II | 1979-03-21 |
| K790279 | CATHETER, MMG LATEX EXTERNAL | Medical Marketing Group | KNX | Class II | 1979-03-06 |
| K790001 | DIALYZER, MODEL F.M.D 150 | Hospal Medical Corp. | FJG | Class II | 1979-03-06 |
| K790271 | TRAY AND BAG, CATHETERIZATION | Snyder Laboratories, Inc. | FCM | Class II | 1979-03-06 |
| K781901 | KANGA PANTS | H.A. & J.E. Wood, Inc. | EYQ | Class I | 1979-03-06 |
| K790272 | TRAY, URETHRAL CATHETERIZATION | Snyder Laboratories, Inc. | FCM | Class II | 1979-03-06 |
| K782057 | CATHETER, RADIOPAQUE TENCKHOFF | Dravon Medical, Inc. | FJS | Class II | 1979-02-27 |
| K782058 | CATHETER, BETA-CAP-PERITONEAL | Dravon Medical, Inc. | FJS | Class II | 1979-02-27 |
| K782151 | ARTIFICIAL KIDNEY, C-DAK 0.6D | Cordis Corp. | FJI | Class II | 1979-02-22 |
| K781966 | DIALYZER, MAGNIFLO 100 PARALLEL PLATE | Erika, Inc. | FJG | Class II | 1979-02-21 |
| K782093 | DETECTOR PAD | Halperin Institute, Ltd. The | KPN | Class II | 1979-02-21 |
| K790091 | AMP AUTOMATIC CYCLER STAND | American Medical Products, Inc. | KPF | Class II | 1979-02-16 |
| K781918 | IRRIGATOR, BODY CAVITY | Bci, Inc. | EYN | Class II | 1979-02-15 |
| K781755 | DAP-PAK | Dravon Medical, Inc. | KDJ | Class II | 1979-02-15 |
| K790174 | BK-6021 CONDOM CATHETER HOLDER | Fred Sammons, Inc. | KNX | Class II | 1979-02-08 |
| K781930 | PANT LINER, DISP. INCONTINENT | Fibre Formations, Inc. | EYQ | Class I | 1979-02-01 |
| K781751 | CATHETER, AKRON FOLEY TEFLON | Latex Ind., Inc. | KOD | Class II | 1979-01-22 |
| K790005 | ADMINISTRATION SET, ENEMA | Kelsar Corp. | FCE | Class I | 1979-01-17 |
| K781886 | DIALYSATE DELIVERY SYSTEM | Cordis Corp. | FKP | Class II | 1979-01-17 |
| K782046 | C-CORD | Concept, Inc. | FFZ | Class II | 1979-01-10 |
| K780527 | CORTRAL I | Hospal Medical Corp. | KDI | Class II | 1978-12-20 |
| K781464 | HEMODIALYZER, MODEL RP610, RP AN 69 | Hospal Medical Corp. | KDI | Class II | 1978-12-20 |
| K781795 | DIALYZER, PARALLEL FLOW DISPOSABLE | Medical, Inc. | FJG | Class II | 1978-12-15 |
| K781032 | AQUA-GEL | Murray, Salk, Inc. | EXQ | Class II | 1978-12-15 |
| K780938 | SUPER-SORBER | Home Healthcare Products, Inc. | EYQ | Class I | 1978-12-15 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.