URINARY LEG BAG
FDA 510(k) clearance K780032 · decided 1978-01-17
Clearance details
- K-number
- K780032
- Device name
- URINARY LEG BAG
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-09
- Decision date
- 1978-01-17
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- FAQ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING (K962604) | Convatec, A Division of E.R. Squibb & Sons | 1996-07-18 |
| CPR URINE BAG (K960217) | Custom Pack Reliability | 1996-03-28 |
| CONVEEN URINE BAG - STERILE (K955609) | Coloplast Corp. | 1995-12-29 |
| PROSYS BEDSIDE DRAINAGE BAG (K953767) | Convatec, A Division of E.R. Squibb & Sons | 1995-12-20 |
| CONVEEN LEG BAG STRAP (K953783) | Coloplast Corp. | 1995-09-13 |
| PROSYS LEG BAG (K951945) | Convatec, A Division of E.R. Squibb & Sons | 1995-05-25 |
| URINE COLLECTOR & ACCESSORIES (K945204) | Nelmed Corp. | 1994-11-02 |
| ALPINE REUSABLE LEG BAGS (K934052) | Sierra Laboratories, Inc. | 1994-01-07 |
| URINARY DRAINAGE BAG CADDY (K931727) | Neotech Products, Inc. | 1993-07-23 |
| BARD LEG BAG HOLDER (K926035) | C.R. Bard, Inc. | 1992-12-17 |
| CONVEEN(R) LEG BAG(500 ML) (K924406) | Coloplast A/S | 1992-10-30 |
| ILC LEG BAG HOLDER (K903611) | Inman Liebelt Corp. | 1990-10-26 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 recall (Z-0732-03) | C.R. Bard, Inc., Urological Division | 2003-04-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |