Cleared Traditional

Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ) (K240389) - FDA 510(k) Clearance

Also marketed or referenced as:
i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240389 · Hyundae Meditech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
48d
Days
Class 2
Risk

K240389 is an FDA 510(k) clearance for the Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ). Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Hyundae Meditech Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on March 27, 2024 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hyundae Meditech Co., Ltd. devices

Submission Details

510(k) Number K240389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2024
Decision Date March 27, 2024
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 26
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K240389.
Suture-TOOL System
K242835 · Suturion AB · Jan 2025
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 FCW1938
K242571 · Hyundae Meditech Co., Ltd. · Sep 2024
1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K232246 · M/s. Meril Endo Surgery Private Limited. · Apr 2024
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
K220549 · Hans Biomed Corporation · Mar 2023
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
K212380 · Ethicon, Inc. · Feb 2022
PDO Max Suture with Dual Needle
K210871 · Pdo Max, Inc. · Dec 2021