FDA 510(k)

G-Series Grind Guard

Número K: K260790 · 2026-06-25

Data da decisão2026-06-25

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

G-Series Grind Guard is the device name listed in this FDA 510(k) record. The listed applicant is ASESSO HEALTH, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K260790. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the G-Series Grind Guard?

G-Series Grind Guard is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is ASESSO HEALTH, Inc.. The 510(k) number is K260790.

When did G-Series Grind Guard receive FDA 510(k) clearance?

G-Series Grind Guard received FDA 510(k) clearance on 2026-06-25, under 510(k) number K260790.

Who is the listed applicant for G-Series Grind Guard?

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

What is the FDA product code for G-Series Grind Guard?

The FDA product code for G-Series Grind Guard is OBR. This falls under the Orthopedic category.

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Fonte oficial

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