510(k) K232372

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) by Peters Surgical — Product Code GAM

K232372 is an FDA 510(k) premarket notification submitted by Peters Surgical for the device "Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)". The FDA issued a decision of Substantially Equivalent on July 12, 2024. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Peters Surgical has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2024
Date Received
August 8, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type