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FDA 510(k)

DemeTECH DemeDIOX absorbable surgical suture

K-Number: K181582 · 2018-08-27

ApplicantDemetech Corporation
Decision Date2018-08-27
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DemeTECH DemeDIOX absorbable surgical suture is a medical device manufactured by Demetech Corporation. It received FDA 510(k) clearance on 2018-08-27 under approval number K181582. 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 DemeTECH DemeDIOX absorbable surgical suture?

DemeTECH DemeDIOX absorbable surgical suture is a medical device that received FDA 510(k) clearance on 2018-08-27. It is manufactured by Demetech Corporation. The 510(k) number is K181582.

When was DemeTECH DemeDIOX absorbable surgical suture approved by the FDA?

DemeTECH DemeDIOX absorbable surgical suture received FDA 510(k) clearance on 2018-08-27, under approval number K181582.

What company makes DemeTECH DemeDIOX absorbable surgical suture?

DemeTECH DemeDIOX absorbable surgical suture is manufactured by Demetech Corporation.

What is the FDA product code for DemeTECH DemeDIOX absorbable surgical suture?

The FDA product code for DemeTECH DemeDIOX absorbable surgical suture is NEW.

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Other Devices by Demetech Corporation

K181578DemeTECH PTFE Nonabsorbable Surgical Suture K191361DemeDIOX Barbed 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. K162366Omega VLOv World 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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