FDA.reportPublic FDA data

510(k) K252047

Device
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
Applicant
ETHICON, Inc.
510(k) number
K252047
Product code
NEW
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-18
Date received
2025-06-30
Regulation
878.4840
Classification name
Suture, Surgical, Absorbable, Polydioxanone
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Samantha Mecker
Address
1000 Rte. 202 S. Raritan NJ US 08869 08869

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NEW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.2025-11-12
K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.2025-10-20
K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.2025-10-15
K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless SutureM/s. Meril Endo Surgery Private Limited.2025-09-23
K250977Suture-TOOL SystemSuturion AB2025-04-28
K242835Suture-TOOL SystemSuturion AB2025-01-22
K242571Secret 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 FCW1938Hyundae Meditech Co., Ltd.2024-09-27
K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless SutureM/s. Meril Endo Surgery Private Limited.2024-04-25
K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)Hyundae Meditech Co., Ltd.2024-03-27
K220549MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014Hans Biomed Corporation2023-03-07
K212380PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureETHICON, Inc.2022-02-22
K210871PDO Max Suture with Dual NeedlePdo Max, Inc.2021-12-17
K201139WEGO-PDO Barbed SutureFoosin Medical Supplies Inc., Ltd.2020-10-20
K192423MINT Product FamilyHans Biomed Corporation2020-09-09
K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.2020-03-25