Fast-Fix 72203986
Fast-Fix 72203986 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K132079 on 5 Dec 2013 and listed in FDA GUDID since 29 Aug 2015 (UDI-DI 00885554032154), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00885554032154 | Date29 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132079 | Date5 Dec 2013 | StatusActive |
Official records
- AccessGUDID record 00885554032154
- FDA 510(k) database K132079
Across registries
- FDA 510(k) K132079 decided 5 Dec 2013 Active
- FDA GUDID UDI-DI 00885554032154 listed 29 Aug 2015 Listed
Recalls
-
- Terminated Z-1822-2015
Sterility of device maybe compromised
Timeline
- Cleared FDA 510(k) K132079
- Recall initiated FDA recalls Z-1822-2015
- Listed FDA GUDID 00885554032154
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fast-Fix
- Generic name
- Polyolefin/fluoropolymer suture, multifilament
- Model / Ref / Catalog
- 72203986
- Primary DI / UDI-DI
- 00885554032154
- 510(k) Number
- FDA product code
- GAT
- GMDN term
- Polyolefin/fluoropolymer suture, multifilament
- Device class
- Class II
- Regulation number
- 878.5000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Polyolefin/fluoropolymer suture, multifilament.