FDA 510(k)

Surgical Sutures with or without Needle

Número K: K221767 · 2023-07-31

RequerenteHuaian Seamen Medical Technology Co., Ltd.

Data da decisão2023-07-31

Código do produtoGAP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Sutures with or without Needle is the device name listed in this FDA 510(k) record. The listed applicant is Huaian Seamen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K221767. 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 Surgical Sutures with or without Needle?

Surgical Sutures with or without Needle is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Huaian Seamen Medical Technology Co., Ltd.. The 510(k) number is K221767.

When did Surgical Sutures with or without Needle receive FDA 510(k) clearance?

Surgical Sutures with or without Needle received FDA 510(k) clearance on 2023-07-31, under 510(k) number K221767.

Who is the listed applicant for Surgical Sutures with or without Needle?

The FDA 510(k) record lists Huaian Seamen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Sutures with or without Needle?

The FDA product code for Surgical Sutures with or without Needle is GAP.

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Dispositivos Relacionados (Código: GAP)

K241486Sofsilk™ Coated Braided Silk SutureCovidien 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.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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