510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K984374Substantially Equivalent

Surgisorb

Samyang Corp., Pleasant Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984374 is the FDA 510(k) clearance record for SURGISORB, a class II device, cleared for Samyang Corp. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 2 510(k) clearances for Samyang Corp., from to . As of , FDA records show no recalls naming K984374.

Clearance record

Decision date
Received
(179 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 Corp. 200 Gregory Ln. Suite C-100, Pleasant Hill CA
510(k) summary
Summary
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