FDA Product Code
FDA Product Code KNX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5250
510(k) Clearances — 206 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K834448 | URINARY DRAINAGE CONTAINER | Vital Metrics, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K833570 | COLOPLAST BABY URINE COLLECTORS | Coloplast A/S | 1984-01-30 | Traditional | PDF ↗ |
| K831530 | PLASTIC LEG BAG | Forever-Dry, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K833245 | SECURITY STRETCH BRIEF-MEDICAL | Mb Products, Ltd. | 1983-10-31 | Traditional | PDF ↗ |
| K832450 | URO-TEX MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K832822 | CLOSED SYS. DRAINAGE BAGS & TRAYS | Medline Industries, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K832526 | UROTRACK PLUS | Vital Metrics, Inc. | 1983-09-19 | Traditional | PDF ↗ |
| K832537 | CONVEEN LEG BAG W/TUBE-DRAINAGE BAG | Telcam Medical Devices, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831622 | MORHEL CLOSED URINARY DRAINAGE SET | Morhel Mexicana | 1983-08-11 | Traditional | PDF ↗ |
| K831796 | URINE BAG SYSTEM | I M, Inc. | 1983-08-08 | Traditional | PDF ↗ |
| K832106 | EXTERNAL INCONTINENCE CATHETER TRAVEL | Plasco, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K832107 | LEG BAG EXTENTION TUBE-STERILE | Plasco, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K832109 | EXTERNAL INCONTINENCE CATHETER TAKE-HOME | Plasco, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K832108 | EXTERNAL INCONTINENCE CATHETER SET-NON | Plasco, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | Fred Sammons, Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K830946 | MALE EXTERNAL CATHETER | Post Medical, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K831121 | CURITY LEG BAG | The Kendal Co. | 1983-04-28 | Traditional | PDF ↗ |
| K830192 | MAC LEE UI URINE COLLECTION BAG | Mac Lee Medical Products | 1983-02-01 | Traditional | PDF ↗ |
| K823716 | CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC | Travenol Laboratories, S.A. | 1983-01-14 | Traditional | PDF ↗ |
| K823450 | FEMALE EXTERNAL URINARY APPLIANCE | Diamed Division Ill. Tool Works, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823411 | PEDIATRIC URINE COLLECTOR | Sage Products, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K822307 | ADHESIVE SPRAY #4050-4060 | The Healthcare Group Laboratories, Inc. | 1982-09-24 | Traditional | PDF ↗ |
| K821979 | STERILE FOLEY CATHETERIZATION KITS | Medical Devices, Inc. | 1982-08-30 | Traditional | PDF ↗ |
| K821978 | STERILE URETHRAL CATHETERIZATION SET | Medical Devices, Inc. | 1982-08-25 | Traditional | PDF ↗ |
| K821848 | ASSURE-MALE EXTERNAL INCONTINCE CATHETER | Medical Design & Manufacturing Corp. | 1982-08-10 | Traditional | PDF ↗ |
| K821829 | UROGARD | Buckman Consultants | 1982-07-30 | Traditional | PDF ↗ |
| K821854 | U-200 BAG | Medical Technologies of Georgia | 1982-07-22 | Traditional | PDF ↗ |
| K821853 | U-100 BAG | Medical Technologies of Georgia | 1982-07-22 | Traditional | PDF ↗ |
| K821168 | DISPOSABLE URINARY LEGBAG W/STRAP | Medical Marketing Group | 1982-05-24 | Traditional | PDF ↗ |
| K821172 | EXTERNAL FEMALE URINARY INCONTINENCE | The Healthcare Group Laboratories, Inc. | 1982-05-10 | Traditional | PDF ↗ |
| K821171 | URINARY COLLECTION CONTAINER/LEG BAG | The Healthcare Group Laboratories, Inc. | 1982-05-10 | Traditional | PDF ↗ |
| K821161 | EXTERNAL URINARY MALE INCONTINENCE DEV | The Healthcare Group Laboratories, Inc. | 1982-05-10 | Traditional | PDF ↗ |
| K820565 | MALE EXTERNAL CATHETER | Urocare Products, Inc. | 1982-04-01 | Traditional | PDF ↗ |
| K813621 | CURITY BEDSIDE DRAINAGE BAG | The Kendal Co. | 1982-02-12 | Traditional | PDF ↗ |
| K820234 | HOLLISTER FEMALE URINARY COLLECT SYS | Hollister, Inc. | 1982-02-10 | Traditional | PDF ↗ |
| K820136 | URINARY DRAINAGE BAG | Megaplast, Inc. | 1982-01-29 | Traditional | PDF ↗ |
| K813537 | URIFIX | Isramed, Inc. | 1982-01-12 | Traditional | PDF ↗ |
| K813479 | ARGYLE PEDIATRIC URINE COLLECTOR | Sherwood Medical Co. | 1982-01-07 | Traditional | PDF ↗ |
| K812907 | FEMEX | Promac | 1981-11-02 | Traditional | PDF ↗ |
| K812249 | SKIN ADHESIVE-50XX | Manfred Sauer Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K812294 | CONVEEN URISHEATH & CONVEEN URILINER | Telcam Medical Devices, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K812250 | CONDOM-52.XX | Manfred Sauer Corp. | 1981-08-20 | Traditional | PDF ↗ |
| K812252 | LATEX LEG BAG-57.XX | Manfred Sauer Corp. | 1981-08-20 | Traditional | PDF ↗ |
| K812251 | DISPOSABLE URINE GAB-70.XX | Manfred Sauer Corp. | 1981-08-20 | Traditional | PDF ↗ |
| K812058 | AKRON URINARY DRAINAGE BAT | Latex Ind., Inc. | 1981-07-31 | Traditional | PDF ↗ |
| K811469 | MMG URINARY DRAINAGE TUBING | Medical Marketing Group | 1981-06-12 | Traditional | PDF ↗ |
| K810645 | SELECT-A-FLOW COLLECTOR | Wenmar Intl. Corp. | 1981-05-05 | Traditional | PDF ↗ |
| K802729 | URINE COLLECTION BAG TYPE 2132V | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802734 | URINE COLLECTION BAG TYPE 710 | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802732 | URINE COLLECTION BAG TYPE AP2132V | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802733 | URINE COLLECTION BAG TYPE AP2090V | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802737 | URINE COLLECTION BAG TYPE 1590V | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802738 | URINE COLLECTION BAG TYPE 1505V | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802739 | URINE COLLECTION BAG TYPE 710AP | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802736 | URINE COOLECTION BAG TYPE 2090V | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802735 | URINE COLLECTION BAG TYPE 740AP | Bio D Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802667 | ARGYLE CLOSED URINARY DRAINAGE SET | Sherwood Medical Co. | 1980-12-16 | Traditional | PDF ↗ |
| K802664 | URINARY DRAINAGE UNT | Diamed Division Ill. Tool Works, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802433 | BARD MALE EXTERNAL CATHETER | C.R. Bard, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K802606 | LEG BAG EXTENSION TUBE | Associated Medical Products Co. | 1980-10-31 | Traditional | PDF ↗ |
| K802173 | URIHESIVE STRIPS | E. R. Squibb & Sons, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K802172 | URIHESIVE SYSTEM | E. R. Squibb & Sons, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K802012 | TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 | Pollak (Intl.), Ltd. | 1980-09-09 | Traditional | PDF ↗ |
| K801711 | BK-6010 CATHETER TUBE HOLDER | Fred Sammons, Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K801629 | COVER-ALL MALE INCONTINENCE DEVICE | The Urology Group | 1980-08-12 | Traditional | PDF ↗ |
| K801021 | URINEBAG | Unovex of Denmark | 1980-07-28 | Traditional | PDF ↗ |
| K801522 | ARGYLE RIGID URINE MEASURING/COLL. DEV. | Sherwood Medical Co. | 1980-07-28 | Traditional | PDF ↗ |
| K800890 | LINEBERGER EXTERNAL MALE CATHETER | Lineberger External Catheter Co. | 1980-06-20 | Traditional | PDF ↗ |
| K800694 | MMG DISPOSABLE URINARY LEG BAG | Medical Marketing Group | 1980-05-30 | Traditional | PDF ↗ |
| K800186 | LOGO-NU-WAY | Gary Giancarlo | 1980-02-26 | Traditional | PDF ↗ |
| K791969 | DYNACOR STERILE CLOSED SYS. DRAINAGE BAG | Medline Industries, Inc. | 1979-11-05 | Traditional | PDF ↗ |
| K791265 | CONPHAR URINARY DRAINAGE BAG-2000ML | Conphar, Inc. | 1979-09-07 | Traditional | PDF ↗ |
| K791252 | CONPHAR FEMALE CATHETER W/BAG-STERILE | Conphar, Inc. | 1979-09-07 | Traditional | PDF ↗ |
| K791262 | CONPHAR URINARY DRAINAGE BAG 2000ML | Conphar, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791245 | CONPHAR EXTERNAL CATHETER | Conphar, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791251 | CONPHAR LEG BAG-STERILE | Conphar, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791270 | CONPHAR LEG BAG | Conphar, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791198 | BIBAG | Ab Medett Produkter | 1979-07-30 | Traditional | PDF ↗ |
| K791196 | URIDROP | Ab Medett Produkter | 1979-07-30 | Traditional | PDF ↗ |
| K790969 | ARGYLE URINE METER | Sherwood Medical Co. | 1979-06-27 | Traditional | PDF ↗ |
| K790253 | URINARY DRAINAGE BAG | Snyder Laboratories, Inc. | 1979-04-10 | Traditional | PDF ↗ |
| K790279 | CATHETER, MMG LATEX EXTERNAL | Medical Marketing Group | 1979-03-06 | Traditional | PDF ↗ |
| K790174 | BK-6021 CONDOM CATHETER HOLDER | Fred Sammons, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781780 | CATHETER, EXTERNAL MALE NURSING CARE | Medi-Tech, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K781521 | CUTTER RESIFLEX URINE METER | Cutter Laboratories, Inc. | 1978-11-22 | Traditional | PDF ↗ |
| K781433 | AKRON MALE EXTERNAL CATHETER | Latex Ind., Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K781422 | KWIK-FLO URINAL SYSTEM | The Grace Mfg. Co. | 1978-09-07 | Traditional | PDF ↗ |
| K780878 | LEG BAG | Abco Dealers, Inc. | 1978-07-31 | Traditional | PDF ↗ |
| K780837 | URINARY DRAINAGE BAG | Intermed, Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K780831 | URINARY CATHETERIZATION SYSTEM W/O FOLEY | Medical Devices, Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K770789 | URI-DRAIN COMBO KIT FOR MALE INCONTINENC | Chesebrough-Pond'S U.S.A. Co. | 1977-10-18 | Traditional | PDF ↗ |
| K771435 | URINARY LEG BAG, STEOILE | Meddev International Corp. | 1977-09-20 | Traditional | PDF ↗ |
| K770762 | BAG, URINARY, DRAINAGE, 2D9013 | Travenol Laboratories, S.A. | 1977-05-10 | Traditional | PDF ↗ |
| K770672 | COLLECTOR, SANI-CATCH, NO. 1010 | Concord Laboratories, Inc. | 1977-04-15 | Traditional | PDF ↗ |
| K770673 | COLLECTOR, SANI-CATCH, NO. 1014 | Concord Laboratories, Inc. | 1977-04-15 | Traditional | PDF ↗ |
| K770516 | MEMBRANE SOURCE-EX SERIES DIALYZER CART. | Extracorporeal Medical Specialities, Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K770557 | DRAINAGE BAG, 4000 ML. | Concord Laboratories, Inc. | 1977-03-24 | Traditional | PDF ↗ |
| K770490 | DRAINAGE BAG, IMPROVED, FLAT | Pharmaseal Div., Baxter Healthcare Corp. | 1977-03-21 | Traditional | PDF ↗ |
| K770497 | DRAINAGE UNIT, COMBINATION | Concord Laboratories, Inc. | 1977-03-21 | Traditional | PDF ↗ |
| K770320 | URINARY DRAINAGE SET, CLOSED, STERILE | Medical Devices, Inc. | 1977-03-16 | Traditional | PDF ↗ |
Product code KNX · Class II · Gastroenterology, Urology. Data: openFDA.