FDA 510(k)

Fios APTOS - Fios Cirúrgicos de Polipropileno

Número K: K192953 · 2020-08-27

Data da decisão2020-08-27

Código do produtoGAW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

APTOS Threads – Polypropylene Surgical Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Aptos, LLC. It received FDA 510(k) clearance on 2020-08-27 under 510(k) number K192953. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the APTOS Threads – Polypropylene Surgical Sutures?

APTOS Threads – Polypropylene Surgical Sutures is a medical device that received FDA 510(k) clearance on 2020-08-27. The listed applicant is Aptos, LLC. The 510(k) number is K192953.

When did APTOS Threads – Polypropylene Surgical Sutures receive FDA 510(k) clearance?

APTOS Threads – Polypropylene Surgical Sutures received FDA 510(k) clearance on 2020-08-27, under 510(k) number K192953.

Who is the listed applicant for APTOS Threads – Polypropylene Surgical Sutures?

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

What is the FDA product code for APTOS Threads – Polypropylene Surgical Sutures?

The FDA product code for APTOS Threads – Polypropylene Surgical Sutures is GAW.

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