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FDA 510(k)

DYNACORD Suture

K-Number: K181182 · 2018-08-02

ApplicantMedos International SARL
Decision Date2018-08-02
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DYNACORD Suture is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181182. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNACORD Suture?

DYNACORD Suture is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Medos International SARL. The 510(k) number is K181182.

When did DYNACORD Suture receive FDA 510(k) clearance?

DYNACORD Suture received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181182.

Who is the listed applicant for DYNACORD Suture?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNACORD Suture?

The FDA product code for DYNACORD Suture is GAT.

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Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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