Stratafix SXPN2B404
by Ethicon Inc.
Stratafix SXPN2B404 is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K253572 on 27 Mar 2026 and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 10705031472921), active as of 9 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10705031472921 | Date29 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK253572 | Date27 Mar 2026 | StatusActive |
Official records
- AccessGUDID record 10705031472921
- FDA 510(k) database K253572
Across registries
- FDA 510(k) K253572 decided 27 Mar 2026 Active
- FDA GUDID UDI-DI 10705031472921 listed 29 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K253572
- Listed FDA GUDID 10705031472921
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stratafix
- Generic name
- Barbed polyolefin/fluoropolymer suture
- Model / Ref / Catalog
- SXPN2B404
- Primary DI / UDI-DI
- 10705031472921
- 510(k) Number
- FDA product code
- GAW
- GMDN term
- Barbed polyolefin/fluoropolymer suture
- Device class
- Class II
- Regulation number
- 878.5010
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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