BAG, DRAINAGEW/ADHESIVE; PROSTHESIS
FDA 510(k) clearance K772366 · decided 1978-01-26
Clearance details
- K-number
- K772366
- Device name
- BAG, DRAINAGEW/ADHESIVE; PROSTHESIS
- Applicant
- Atlantic Surgical
- Decision
- Substantially Equivalent
- Date received
- 1977-12-27
- Decision date
- 1978-01-26
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- FON
- Device class
- 1
- Regulation number
- 876.5900
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Atlantic Surgical
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 |
|---|---|---|
| HOLLISTER DRAINAGE POUCH (K801504) | Hollister, Inc. | 1980-08-12 |
| POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE (K770826) | Howmedica Corp. | 1977-06-28 |
Recalls involving this device
No recalls on record reference this clearance.