Cleared Special

K242571 - Secret Line up (FC1938E80 FC1950E90 FC1...

K242571 is an FDA 510(k) clearance for Secret Line up (FC1938E80 FC1950E90 FC1..., manufactured by Hyundae Meditech Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Special 510(k) pathway after a 29-day FDA review.

K242571 · Hyundae Meditech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
29d
Days
Class 2
Risk

K242571 is an FDA 510(k) clearance for the Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E.... 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 September 27, 2024 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hyundae Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K242571

510(k) Number K242571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2024
Decision Date September 27, 2024
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

NEW Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K242571.
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644 · M/s. Meril Endo Surgery Private Limited. · Sep 2025
Suture-TOOL System
K250977 · Suturion AB · Apr 2025
Suture-TOOL System
K242835 · Suturion AB · Jan 2025
1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K232246 · M/s. Meril Endo Surgery Private Limited. · Apr 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
K240389 · Hyundae Meditech Co., Ltd. · Mar 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