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FDA 510(k)

MONOFIX PDO

K-Number: K253879 · 2026-08-25

ApplicantSamyang Holdings Corporation
Decision Date2026-08-25
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOFIX PDO is the device name listed in this FDA 510(k) record. The listed applicant is Samyang Holdings Corporation. It received FDA 510(k) clearance on 2026-08-25 under 510(k) number K253879. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOFIX PDO?

MONOFIX PDO is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Samyang Holdings Corporation. The 510(k) number is K253879.

When did MONOFIX PDO receive FDA 510(k) clearance?

MONOFIX PDO received FDA 510(k) clearance on 2026-08-25, under 510(k) number K253879.

Who is the listed applicant for MONOFIX PDO?

The FDA 510(k) record lists Samyang Holdings Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOFIX PDO?

The FDA product code for MONOFIX PDO is NEW.

Other records listing Samyang Holdings Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212810MONOFIX PGCL, knotless wound closure device

Related Devices (Code: NEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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