PROSYS LEG BAG
FDA 510(k) clearance K951945 · decided 1995-05-25
Clearance details
- K-number
- K951945
- Device name
- PROSYS LEG BAG
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
- Decision
- Substantially Equivalent
- Date received
- 1995-04-26
- Decision date
- 1995-05-25
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FAQ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Convatec
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| EXTERNAL LEG BAG (K901219) | Orion Life Systems, Inc. | 1990-06-27 |
Recalls involving this device
No recalls on record reference this clearance.