510(k) K222487
K222487 is an FDA 510(k) premarket notification submitted by Anika Therapeutics, Inc. for the device "Anika Tissue Tack Fixation System". The FDA issued a decision of Substantially Equivalent on May 8, 2023. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Anika Therapeutics, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2023
- Date Received
- August 17, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type