FDA 510(k)

SCOUT MD Surgical Guidance System

Número K: K252892 · 2025-12-19

Data da decisão2025-12-19

Código do produtoNEU

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SCOUT MD Surgical Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252892. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SCOUT MD Surgical Guidance System?

SCOUT MD Surgical Guidance System is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K252892.

When did SCOUT MD Surgical Guidance System receive FDA 510(k) clearance?

SCOUT MD Surgical Guidance System received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252892.

Who is the listed applicant for SCOUT MD Surgical Guidance System?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCOUT MD Surgical Guidance System?

The FDA product code for SCOUT MD Surgical Guidance System is NEU.

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Fonte oficial

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