SIC Graft 10050
by Xiros Ltd
SIC Graft 10050 is a Class II device made by Xiros Ltd, cleared under FDA 510(k) K222978 on 27 Dec 2022 and listed in FDA GUDID since 7 Aug 2025 (UDI-DI 05060267134271), active as of 22 Oct 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 | Number05060267134271 | Date7 Aug 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222978 | Date27 Dec 2022 | StatusActive |
Official records
- AccessGUDID record 05060267134271
- FDA 510(k) database K222978
Across registries
- FDA 510(k) K222978 decided 27 Dec 2022 Active
- FDA GUDID UDI-DI 05060267134271 listed 7 Aug 2025 Listed
Timeline
- Cleared FDA 510(k) K222978
- Listed FDA GUDID 05060267134271
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SIC Graft
- Generic name
- Surgical support tape, non-bioabsorbable
- Model / reference
- 10050
- Primary DI / UDI-DI
- 05060267134271
- 510(k) Number
- FDA product code
- FTL, QUW, OWX
- GMDN term
- Surgical support tape, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Surgical support tape, non-bioabsorbable.