FDA 510(k)

GluStitch Twist Tissue Adhesive

Número K: K150032 · 2016-01-14

Data da decisão2016-01-14

Código do produtoMPN

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GluStitch Twist Tissue Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Glustitch, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K150032. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GluStitch Twist Tissue Adhesive?

GluStitch Twist Tissue Adhesive is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Glustitch, Inc.. The 510(k) number is K150032.

When did GluStitch Twist Tissue Adhesive receive FDA 510(k) clearance?

GluStitch Twist Tissue Adhesive received FDA 510(k) clearance on 2016-01-14, under 510(k) number K150032.

Who is the listed applicant for GluStitch Twist Tissue Adhesive?

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

What is the FDA product code for GluStitch Twist Tissue Adhesive?

The FDA product code for GluStitch Twist Tissue Adhesive is MPN.

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