510(k) K212146
K212146 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex LoopLoc Knotless Suture". The FDA issued a decision of Substantially Equivalent on Oct 25, 2021. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Arthrex, Inc. has 352 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 2021
- Date Received
- Jul 9, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type
- 510(k)