510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K212810Substantially Equivalent

MONOFIX PGCL, knotless wound closure device

Samyang Holdings Corp., Ltd., Daedeok-Gu, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212810 is the FDA 510(k) clearance record for MONOFIX PGCL, knotless wound closure device, a class II device, cleared for Samyang Holdings Corp., Ltd. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list one 510(k) clearance for Samyang Holdings Corp., Ltd. As of , FDA records show no recalls naming K212810.

Clearance record

Decision date
Received
(336 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Samyang Holdings Corp., Ltd. 55, Munpyeongseo-Ro, 18beon-Gil, Daedeok-Gu, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
6 clearances under product code GAM in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260