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FDA 510(k)

DemeDIOX Barbed Absorbable Surgical Suture

K-Number: K191361 · 2019-11-07

ApplicantDemetech Corporation
Decision Date2019-11-07
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DemeDIOX Barbed Absorbable 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 2019-11-07 under 510(k) number K191361. 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 DemeDIOX Barbed Absorbable Surgical Suture?

DemeDIOX Barbed Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Demetech Corporation. The 510(k) number is K191361.

When did DemeDIOX Barbed Absorbable Surgical Suture receive FDA 510(k) clearance?

DemeDIOX Barbed Absorbable Surgical Suture received FDA 510(k) clearance on 2019-11-07, under 510(k) number K191361.

Who is the listed applicant for DemeDIOX Barbed Absorbable 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 DemeDIOX Barbed Absorbable Surgical Suture?

The FDA product code for DemeDIOX Barbed Absorbable Surgical Suture 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) 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.

K201479DemeMASKK190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureK181578DemeTECH PTFE Nonabsorbable Surgical SutureK181582DemeTECH DemeDIOX absorbable surgical suture

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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