FDA 510(k)

Fio de Sutura Cirúrgica Não Absorvível

Número K: K232355 · 2024-01-16

RequerenteShandong Haidike Medical Product Co., Ltd.

Data da decisão2024-01-16

Código do produtoGAP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non absorbable Surgical Silk Suture is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Haidike Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K232355. 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 Non absorbable Surgical Silk Suture?

Non absorbable Surgical Silk Suture is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Shandong Haidike Medical Product Co., Ltd.. The 510(k) number is K232355.

When did Non absorbable Surgical Silk Suture receive FDA 510(k) clearance?

Non absorbable Surgical Silk Suture received FDA 510(k) clearance on 2024-01-16, under 510(k) number K232355.

Who is the listed applicant for Non absorbable Surgical Silk Suture?

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

What is the FDA product code for Non absorbable Surgical Silk Suture?

The FDA product code for Non absorbable Surgical Silk Suture is GAP.

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Outros registros que listam Shandong Haidike Medical Product Co., Ltd. como candidato(a)

K212603Non Absorbable Surgical Nylon Suture

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.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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