FDA 510(k)

Sofsilk™ Coated Braided Silk Suture

Número K: K241486 · 2024-12-03

Data da decisão2024-12-03

Código do produtoGAP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sofsilk™ Coated Braided Silk Suture is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2024-12-03 under 510(k) number K241486. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sofsilk™ Coated Braided Silk Suture?

Sofsilk™ Coated Braided Silk Suture is a medical device that received FDA 510(k) clearance on 2024-12-03. The listed applicant is Covidien. The 510(k) number is K241486.

When did Sofsilk™ Coated Braided Silk Suture receive FDA 510(k) clearance?

Sofsilk™ Coated Braided Silk Suture received FDA 510(k) clearance on 2024-12-03, under 510(k) number K241486.

Who is the listed applicant for Sofsilk™ Coated Braided Silk Suture?

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

What is the FDA product code for Sofsilk™ Coated Braided Silk Suture?

The FDA product code for Sofsilk™ Coated Braided Silk Suture is GAP.

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Dispositivos Relacionados (Código: GAP)

K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Fio de Sutura Cirúrgica Não AbsorvívelShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.K162396SILK Surgical SutureTeleflexmedical, Inc.

Fonte oficial

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