CONVEEN URINE BAG - STERILE
FDA 510(k) clearance K955609 · decided 1995-12-29
Clearance details
- K-number
- K955609
- Device name
- CONVEEN URINE BAG - STERILE
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-08
- Decision date
- 1995-12-29
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FAQ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marietta, GA, 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 |
| 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 |
| EXTERNAL LEG BAG (K901219) | Orion Life Systems, Inc. | 1990-06-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Titan Inflatable Penile Prosthesis (P000006/S071) | Coloplast Corp. | 2025-08-14 |
| Titan Inflatable Penile Prosthesis (P000006/S070) | Coloplast Corp. | 2025-05-28 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S069) | Coloplast Corp. | 2024-10-02 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S068) | Coloplast Corp. | 2024-07-09 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S067) | Coloplast Corp. | 2024-02-05 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S064) | Coloplast Corp. | 2023-03-03 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S066) | Coloplast Corp. | 2023-02-15 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S065) | Coloplast Corp. | 2023-01-12 |