Arthrex Speedcinch
510(k) K132043
Arthrex Speedcinch is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K132043 on 31 Jul 2013, 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 | NumberK132043 | Date31 Jul 2013 | StatusActive |
Official records
- FDA 510(k) database K132043
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- Withdrawn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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