FDA 510(k)

Clench Compression Staple

Número K: K173775 · 2018-04-06

RequerenteF & A Foundation, LLC D.B.A. Reign Medical

Data da decisão2018-04-06

Código do produtoJDR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clench Compression Staple is the device name listed in this FDA 510(k) record. The listed applicant is F & A Foundation, LLC D.B.A. Reign Medical. It received FDA 510(k) clearance on 2018-04-06 under 510(k) number K173775. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Clench Compression Staple?

Clench Compression Staple is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is F & A Foundation, LLC D.B.A. Reign Medical. The 510(k) number is K173775.

When did Clench Compression Staple receive FDA 510(k) clearance?

Clench Compression Staple received FDA 510(k) clearance on 2018-04-06, under 510(k) number K173775.

Who is the listed applicant for Clench Compression Staple?

The FDA 510(k) record lists F & A Foundation, LLC D.B.A. Reign Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clench Compression Staple?

The FDA product code for Clench Compression Staple is JDR.

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