Arthrex BioSuture
510(k) K220880
Arthrex BioSuture is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K220880 on 27 Oct 2022, 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 | FDA 510(k)SESE | NumberK220880 | Date27 Oct 2022 | StatusActive |
Official records
- FDA 510(k) database K220880
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GAT
- Device class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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