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FDA 510(k)

WEGO-PDO Barbed Suture

K-Number: K201139 · 2020-10-20

ApplicantFoosin Medical Supplies Inc., Ltd.
Decision Date2020-10-20
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WEGO-PDO Barbed Suture is the device name listed in this FDA 510(k) record. The listed applicant is Foosin Medical Supplies Inc., Ltd.. It received FDA 510(k) clearance on 2020-10-20 under 510(k) number K201139. 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 WEGO-PDO Barbed Suture?

WEGO-PDO Barbed Suture is a medical device that received FDA 510(k) clearance on 2020-10-20. The listed applicant is Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K201139.

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

WEGO-PDO Barbed Suture received FDA 510(k) clearance on 2020-10-20, under 510(k) number K201139.

Who is the listed applicant for WEGO-PDO Barbed Suture?

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

What is the FDA product code for WEGO-PDO Barbed Suture?

The FDA product code for WEGO-PDO Barbed Suture is NEW.

Related Clinical Trials

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.

NCT06404372To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) SutureCOMPLETED

Other records listing Foosin Medical Supplies Inc., Ltd. 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.

K193209Wego-Stainless SteelK183004WEGO-PGA RAPIDK183001WEGO-PGLA RAPIDK170842WEGO-PTFE

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

View on FDA Database →

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

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