FDA 510(k)

PDO Max Suture with Dual Needle

K-Number: K210871 · 2021-12-17

Decision Date2021-12-17

Product CodeNEW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PDO Max Suture with Dual Needle is a medical device manufactured by Pdo Max, Inc.. It received FDA 510(k) clearance on 2021-12-17 under approval number K210871. 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 PDO Max Suture with Dual Needle?

PDO Max Suture with Dual Needle is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Pdo Max, Inc.. The 510(k) number is K210871.

When was PDO Max Suture with Dual Needle approved by the FDA?

PDO Max Suture with Dual Needle received FDA 510(k) clearance on 2021-12-17, under approval number K210871.

What company makes PDO Max Suture with Dual Needle?

PDO Max Suture with Dual Needle is manufactured by Pdo Max, Inc..

What is the FDA product code for PDO Max Suture with Dual Needle?

The FDA product code for PDO Max Suture with Dual Needle is NEW.

Other Devices by Pdo Max, Inc.

K190245PDS Barbed Suture, PDO MAXX Threads

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

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