510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240389Substantially Equivalent

Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)

Hyundae Meditech Co., Ltd., Wonju-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240389 is the FDA 510(k) clearance record for Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150), a class II device, cleared for Hyundae Meditech Co., Ltd. on under FDA product code NEW (Suture, Surgical, Absorbable, Polydioxanone). FDA records list 2 510(k) clearances for Hyundae Meditech Co., Ltd., from to . As of , FDA records show no recalls naming K240389.

Clearance record

Decision date
Received
(48 days to decision)
Product code
NEW Suture, Surgical, Absorbable, Polydioxanone
Regulation
21 CFR 878.4840
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Hyundae Meditech Co., Ltd. 80, Cheongjeong-Ro, Jijeong-Myeon,, Wonju-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEW

Trailing 12 months
6 clearances under product code NEW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NEW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20261
August 20261
September 20261
October 20260