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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 a medical device manufactured by Foosin Medical Supplies Inc., Ltd.. It received FDA 510(k) clearance on 2020-10-20 under approval 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. It is manufactured by Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K201139.

When was WEGO-PDO Barbed Suture approved by the FDA?

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

What company makes WEGO-PDO Barbed Suture?

WEGO-PDO Barbed Suture is manufactured by Foosin Medical Supplies Inc., Ltd..

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

NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT05433688 Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery ACTIVE_NOT_RECRUITING NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

Other Devices by Foosin Medical Supplies Inc., Ltd.

K170842WEGO-PTFE K183004WEGO-PGA RAPID K183001WEGO-PGLA RAPID K193209Wego-Stainless Steel

Related Devices (Code: NEW)

K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. K160761DW-1CDongwon Medical Co., Ltd. K150553FilblocAssut Europe K161737RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX UndyedMyco Medical K172602MiracuFeeltech Co., Ltd. K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation

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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