4 SURE TM COLOSTOMY POUCH
FDA 510(k) clearance K922401 · decided 1992-06-10
Clearance details
- K-number
- K922401
- Device name
- 4 SURE TM COLOSTOMY POUCH
- Applicant
- Boston Pacific Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-21
- Decision date
- 1992-06-10
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- EZQ
- Device class
- 1
- Regulation number
- 876.5900
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Boston, MA, 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 |
|---|---|---|
| VITALA CONTINENCE CONTROL DEVICE (K111365) | Convatec, Inc. | 2011-08-19 |
| VITALA CONTINENCE CONTROL DEVICE (K102536) | Convatec, Inc. | 2010-12-01 |
| VITALA CONTINENCE CONTROL DEVICE (K083785) | Convatec | 2010-04-02 |
| MARLEN ULTRA ILEOSTOMY POUCH-5000 (K880327) | Marlen Mfg. & Development Co. | 1988-02-19 |
| CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM (K863830) | Coloplast A/S | 1986-10-16 |
Recalls involving this device
No recalls on record reference this clearance.