510(k) K220186

Zone Specific AIM by Conmed Corporation — Product Code GAT

K220186 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "Zone Specific AIM". The FDA issued a decision of Substantially Equivalent on May 13, 2022. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Conmed Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
January 24, 2022
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