510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200392Substantially Equivalent

Rexsin

Sm Eng Co., Ltd., Sasang-Gu, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200392 is the FDA 510(k) clearance record for REXSIN, a class II device, cleared for Sm Eng Co., Ltd. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 5 510(k) clearances for Sm Eng Co., Ltd., from to . As of , FDA records show no recalls naming K200392.

Clearance record

Decision date
Received
(140 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
Sm Eng Co., Ltd. 46, Nakdong-Daero 1302beon-Gil, Sasang-Gu, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
5 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 20260
October 20260