FDA 510(k)

MONOFIX PGCL, knotless wound closure device

Номер K: K212810 · 2022-08-05

Дата решения2022-08-05

Код продуктаGAM

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GAM)

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

Официальный источник

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