Product code EZQ
- Device name
- Pouch, Colostomy
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5900
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111365 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | 2011-08-19 |
| K102536 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | 2010-12-01 |
| K083785 | VITALA CONTINENCE CONTROL DEVICE | Convatec | 2010-04-02 |
| K922401 | 4 SURE TM COLOSTOMY POUCH | Boston Pacific Medical, Inc. | 1992-06-10 |
| K880327 | MARLEN ULTRA ILEOSTOMY POUCH-5000 | Marlen Mfg. & Development Co. | 1988-02-19 |
| K863830 | CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM | Coloplast A/S | 1986-10-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00768455102549 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-29 |
| 00768455102532 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455102525 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455102518 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455102563 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455102570 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455102587 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455102594 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455102136 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2019-03-22 |
| 00768455103386 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455103393 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455103409 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455103416 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455103423 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455103430 | SUR-FIR NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455103447 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455103454 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2018-12-07 |
| 00768455102501 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102495 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102488 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102471 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102457 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102433 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102426 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102419 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102402 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102396 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102389 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102372 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455102365 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |