FDA 510(k)

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture

K-Nummer: K261988 · 2026-07-09

Entscheidungsdatum2026-07-09

ProduktcodeNEW

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical, LLC. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261988. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture?

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Teleflex Medical, LLC. The 510(k) number is K261988.

When did Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture receive FDA 510(k) clearance?

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261988.

Who is the listed applicant for Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture?

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

What is the FDA product code for Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture?

The FDA product code for Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture is NEW.

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Weitere Einträge mit Teleflex Medical, LLC als Antragsteller

K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™

Verwandte Geräte (Code: NEW)

K254238MINT MONO SuturesHans Biomed Corporation K253879MONOFIX PDOSamyang Holdings Corporation K252171Barbed 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.

Offizielle Quelle

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