FDA 510(k)

MONOFIX PGCL, knotless wound closure device

Número K: K212810 · 2022-08-05

Data da decisão2022-08-05

Código do produtoGAM

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MONOFIX PGCL, knotless wound closure device is the device name listed in this FDA 510(k) record. The listed applicant is Samyang Holdings Corp., Ltd.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K212810. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MONOFIX PGCL, knotless wound closure device?

MONOFIX PGCL, knotless wound closure device is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Samyang Holdings Corp., Ltd.. The 510(k) number is K212810.

When did MONOFIX PGCL, knotless wound closure device receive FDA 510(k) clearance?

MONOFIX PGCL, knotless wound closure device received FDA 510(k) clearance on 2022-08-05, under 510(k) number K212810.

Who is the listed applicant for MONOFIX PGCL, knotless wound closure device?

The FDA 510(k) record lists Samyang Holdings Corp., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOFIX PGCL, knotless wound closure device?

The FDA product code for MONOFIX PGCL, knotless wound closure device is GAM.

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