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FDA 510(k)

PDS Barbed Suture, PDO MAXX Threads

K-Number: K190245 · 2019-06-04

ApplicantPdo Max, Inc.
Decision Date2019-06-04
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDS Barbed Suture, PDO MAXX Threads is a medical device manufactured by Pdo Max, Inc.. It received FDA 510(k) clearance on 2019-06-04 under approval number K190245. 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 PDS Barbed Suture, PDO MAXX Threads?

PDS Barbed Suture, PDO MAXX Threads is a medical device that received FDA 510(k) clearance on 2019-06-04. It is manufactured by Pdo Max, Inc.. The 510(k) number is K190245.

When was PDS Barbed Suture, PDO MAXX Threads approved by the FDA?

PDS Barbed Suture, PDO MAXX Threads received FDA 510(k) clearance on 2019-06-04, under approval number K190245.

What company makes PDS Barbed Suture, PDO MAXX Threads?

PDS Barbed Suture, PDO MAXX Threads is manufactured by Pdo Max, Inc..

What is the FDA product code for PDS Barbed Suture, PDO MAXX Threads?

The FDA product code for PDS Barbed Suture, PDO MAXX Threads 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 Pdo Max, Inc.

K210871PDO Max Suture with Dual Needle

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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