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FDA 510(k)

DemeDIOX Barbed Absorbable Surgical Suture

K-Number: K191361 · 2019-11-07

ApplicantDemetech Corporation
Decision Date2019-11-07
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DemeDIOX Barbed Absorbable Surgical Suture is a medical device manufactured by Demetech Corporation. It received FDA 510(k) clearance on 2019-11-07 under approval number K191361. 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 DemeDIOX Barbed Absorbable Surgical Suture?

DemeDIOX Barbed Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Demetech Corporation. The 510(k) number is K191361.

When was DemeDIOX Barbed Absorbable Surgical Suture approved by the FDA?

DemeDIOX Barbed Absorbable Surgical Suture received FDA 510(k) clearance on 2019-11-07, under approval number K191361.

What company makes DemeDIOX Barbed Absorbable Surgical Suture?

DemeDIOX Barbed Absorbable Surgical Suture is manufactured by Demetech Corporation.

What is the FDA product code for DemeDIOX Barbed Absorbable Surgical Suture?

The FDA product code for DemeDIOX Barbed Absorbable Surgical Suture is NEW.

Related Clinical Trials

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Other Devices by Demetech Corporation

K181578DemeTECH PTFE Nonabsorbable Surgical Suture K181582DemeTECH DemeDIOX absorbable surgical suture K190777DemeTECH DemeFORCE Nonabsorbable Surgical Suture K201479DemeMASK

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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