FDA 510(k)

SurgiPure XD Reconstructive Tissue Matrix

Número K: K152206 · 2016-03-08

Data da decisão2016-03-08

Código do produtoFTM

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SurgiPure XD Reconstructive Tissue Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regenix Group Plc. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K152206. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SurgiPure XD Reconstructive Tissue Matrix?

SurgiPure XD Reconstructive Tissue Matrix is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Tissue Regenix Group Plc. The 510(k) number is K152206.

When did SurgiPure XD Reconstructive Tissue Matrix receive FDA 510(k) clearance?

SurgiPure XD Reconstructive Tissue Matrix received FDA 510(k) clearance on 2016-03-08, under 510(k) number K152206.

Who is the listed applicant for SurgiPure XD Reconstructive Tissue Matrix?

The FDA 510(k) record lists Tissue Regenix Group Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiPure XD Reconstructive Tissue Matrix?

The FDA product code for SurgiPure XD Reconstructive Tissue Matrix is FTM.

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