Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ) +1 more— 510(k) K240389

Clearance details

Device name as filed

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

Applicant

Hyundae Meditech Co., Ltd.

Product code

Code NEW

Device class

Class 2

Regulation

21 CFR 878.4840

Advisory panel

General, Plastic Surgery

Date received

2024-02-08

Decision date

2024-03-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wonju-Si, KR

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• K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18
• K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture2025-11-12

• K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW19382024-09-27

Death

32

Injury

2,179

Malfunction

8,975

Total

11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →