510(k) K133770
K133770 is an FDA 510(k) premarket notification submitted by Anchor Innovation Medical (A.I.M.) for the device "A.I.M. KNOTLESS MENISCAL REPAIR DEVICE". The FDA issued a decision of Substantially Equivalent on June 10, 2014. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Anchor Innovation Medical (A.I.M.) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2014
- Date Received
- December 11, 2013
- 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