FDA 510(k)

Barbed PDO Suture

Numéro K : K252171 · 2026-06-12

DemandeurSutura Medical Technology, Inc.

Date de décision2026-06-12

Code produitNEW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Barbed PDO Suture is the device name listed in this FDA 510(k) record. The listed applicant is Sutura Medical Technology, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252171. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Barbed PDO Suture?

Barbed PDO Suture is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Sutura Medical Technology, Inc.. The 510(k) number is K252171.

When did Barbed PDO Suture receive FDA 510(k) clearance?

Barbed PDO Suture received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252171.

Who is the listed applicant for Barbed PDO Suture?

The FDA 510(k) record lists Sutura Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barbed PDO Suture?

The FDA product code for Barbed PDO Suture is NEW.

Essais cliniques associés

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Dispositifs connexes (Code : NEW)

K254238MINT MONO SuturesHans Biomed Corporation K253879MONOFIX PDOSamyang Holdings Corporation K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC 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.

Source officielle

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