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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 the device name listed in this FDA 510(k) record. The listed applicant is Pdo Max, Inc.. It received FDA 510(k) clearance on 2019-06-04 under 510(k) 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. The listed applicant is Pdo Max, Inc.. The 510(k) number is K190245.

When did PDS Barbed Suture, PDO MAXX Threads receive FDA 510(k) clearance?

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

Who is the listed applicant for PDS Barbed Suture, PDO MAXX Threads?

The FDA 510(k) record lists Pdo Max, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06404372To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) SutureCOMPLETEDNCT07574086Stratafix vs. PDS (Fascial Closure RCT)NOT_YET_RECRUITING

Other records listing Pdo Max, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210871PDO Max Suture with Dual Needle

Related Devices (Code: NEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech 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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