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 FCRL1870C1

Q: What is the product code of K242571?

The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.

FDA 510(k) K242571 · Hyundae Meditech Co., Ltd.

Substantially Equivalent

510(k) numberK242571

Submission

Device name: 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 FCRL1870C1
Applicant: Hyundae Meditech Co., Ltd.
Wonju-Si, KR
Received: August 29, 2024
Decision date: September 27, 2024
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NEW – Suture, Surgical, Absorbable, Polydioxanone
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4840
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code NEW

510(k)	Device	Applicant	Decision
K253879	Monofix PdoNEW · Traditional	Samyang Holdings Corporation	08/25/2026SE
K261988	Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special	Teleflex Medical, LLC	07/09/2026SE
K252171	Barbed PDO SutureNEW · Traditional	Sutura Medical Technology, Inc.	06/12/2026SE
K252047	STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional	ETHICON, Inc.	05/18/2026SE
K243897	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional	ETHICON, Inc.	11/12/2025SE
K251414	Miracu Polydioxanone (PDO) Suture and Needle (MONO)NEW · Traditional	Feeltech Co., Ltd.	10/20/2025SE
K250107	V-soft Line Barbed Surgical Suture (Various)NEW · Traditional	Feeltech Co., Ltd.	10/15/2025SE
K252644	PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special	M/s. Meril Endo Surgery Private Limited.	09/23/2025SE
K250977	Suture-TOOL SystemNEW · Special	Suturion AB	04/28/2025SE
K242835	Suture-TOOL SystemNEW · Traditional	Suturion AB	01/22/2025SE

More from Suturion AB

510(k)	Device	Decision
K240389	Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…NEW · Traditional	03/27/2024SE

Questions and answers

When was 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 FCRL1870C1 cleared by the FDA?

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 FCRL1870C1 (K242571) received a 510(k) decision of Substantially Equivalent on September 27, 2024, 29 days after the submission was received.

What is the product code of K242571?

The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.