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FDA 510(k)

PDO Max Suture with Dual Needle

K-Number: K210871 · 2021-12-17

ApplicantPdo Max, Inc.
Decision Date2021-12-17
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDO Max Suture with Dual Needle 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 2021-12-17 under 510(k) 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. The listed applicant is Pdo Max, Inc.. The 510(k) number is K210871.

When did PDO Max Suture with Dual Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for PDO Max Suture with Dual Needle?

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 PDO Max Suture with Dual Needle?

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

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.

K190245PDS Barbed Suture, PDO MAXX Threads

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

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

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