510(k) K222487

Anika Tissue Tack Fixation System by Anika Therapeutics, Inc. — Product Code GDW

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