Panels › Gastroenterology, Urology › Product code FAQ · Class 1
Bag, Urine Collection, Leg, For External Use, Sterile
Regulation 876.5250
0510(k)s in 12 months (18 all time)
0recalls in 12 months (7 all time)
1recalls that name a 510(k)
Top companies in FAQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Convatec, A Division of E.R. Squibb & Sons | 3 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 3 |
| C.R. Bard, Inc. | 2 | 0 |
| Coloplast Corp. | 2 | 0 |
| Teleflex Medical | 0 | 2 |
| Baka Manufacturing Co., Inc. | 1 | 0 |
| The Boston & Pacific Co., Inc. | 1 | 0 |
| C.R. Bard, Inc., Urological Division | 0 | 1 |
| Coloplast A/S | 1 | 0 |
| Custom Pack Reliability | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 18, 1996 | K962604 | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING Convatec, A Division of E.R. Squibb & Sons | FAQ |
| Mar 28, 1996 | K960217 | CPR URINE BAG Custom Pack Reliability | FAQ |
| Dec 29, 1995 | K955609 | CONVEEN URINE BAG - STERILE Coloplast Corp. | FAQ |
| Dec 20, 1995 | K953767 | PROSYS BEDSIDE DRAINAGE BAG Convatec, A Division of E.R. Squibb & Sons | FAQ |
| Sep 13, 1995 | K953783 | CONVEEN LEG BAG STRAP Coloplast Corp. | FAQ |
| May 25, 1995 | K951945 | PROSYS LEG BAG Convatec, A Division of E.R. Squibb & Sons | FAQ |
| Nov 2, 1994 | K945204 | URINE COLLECTOR & ACCESSORIES Nelmed Corp. | FAQ |
| Jan 7, 1994 | K934052 | ALPINE REUSABLE LEG BAGS Sierra Laboratories, Inc. | FAQ |
| Jul 23, 1993 | K931727 | URINARY DRAINAGE BAG CADDY Neotech Products, Inc. | FAQ |
| Dec 17, 1992 | K926035 | BARD LEG BAG HOLDER C.R. Bard, Inc. | FAQ |
| Oct 30, 1992 | K924406 | CONVEEN(R) LEG BAG(500 ML) Coloplast A/S | FAQ |
| Oct 26, 1990 | K903611 | ILC LEG BAG HOLDER Inman Liebelt Corp. | FAQ |
| Jun 27, 1990 | K901219 | EXTERNAL LEG BAG Orion Life Systems, Inc. | FAQ |
| Apr 16, 1990 | K896129 | URINARY LEG BAG Cypress Medical Products, Ltd. | FAQ |
| Feb 20, 1990 | K896728 | 4 SURE URINARY LEG BAG The Boston & Pacific Co., Inc. | FAQ |
| Feb 21, 1978 | K780190 | CATHETER STRAP & RUINARY BAY HOLDER Baka Manufacturing Co., Inc. | FAQ |
| Jan 26, 1978 | K772402 | QUADRIPLEGIC URINARY DRAINAGE VALVE Fred Sammons, Inc. | FAQ |
| Jan 17, 1978 | K780032 | URINARY LEG BAG C.R. Bard, Inc. | FAQ |
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