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FDA 510(k)

DemeTECH DemeFORCE Nonabsorbable Surgical Suture

K-Number: K190777 · 2019-07-31

ApplicantDemetech Corporation
Decision Date2019-07-31
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DemeTECH DemeFORCE Nonabsorbable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corporation. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K190777. 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 DemeTECH DemeFORCE Nonabsorbable Surgical Suture?

DemeTECH DemeFORCE Nonabsorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Demetech Corporation. The 510(k) number is K190777.

When did DemeTECH DemeFORCE Nonabsorbable Surgical Suture receive FDA 510(k) clearance?

DemeTECH DemeFORCE Nonabsorbable Surgical Suture received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190777.

Who is the listed applicant for DemeTECH DemeFORCE Nonabsorbable Surgical Suture?

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

What is the FDA product code for DemeTECH DemeFORCE Nonabsorbable Surgical Suture?

The FDA product code for DemeTECH DemeFORCE Nonabsorbable Surgical Suture is GAT.

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) SutureCOMPLETED

Other records listing Demetech Corporation 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.

K201479DemeMASKK191361DemeDIOX Barbed Absorbable Surgical SutureK181578DemeTECH PTFE Nonabsorbable Surgical SutureK181582DemeTECH DemeDIOX absorbable surgical suture

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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