SutureTape
510(k) K171296
SutureTape is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K171296 on 26 May 2017, 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 | NumberK171296 | Date26 May 2017 | StatusActive |
Official records
- FDA 510(k) database K171296
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- Withdrawn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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Other devices filed under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).
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