FDA 510(k)

Sutura de Seda Quirúrgica No Absorbible

N.º K: K232355 · 2024-01-16

SolicitanteShandong Haidike Medical Product Co., Ltd.

Fecha de decisión2024-01-16

Código de productoGAP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Shandong Haidike Medical Product Co., Ltd. como solicitante

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.

Fuente oficial

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