FDA 510(k)

GSPE Spacer

Número K: K260063 · 2026-09-11

RequerenteThe General Hospital Corporation, d/b/a Massachusetts

Data da decisão2026-09-11

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

GSPE Spacer is the device name listed in this FDA 510(k) record. The listed applicant is The General Hospital Corporation, d/b/a Massachusetts. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K260063. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GSPE Spacer?

GSPE Spacer is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is The General Hospital Corporation, d/b/a Massachusetts. The 510(k) number is K260063.

When did GSPE Spacer receive FDA 510(k) clearance?

GSPE Spacer received FDA 510(k) clearance on 2026-09-11, under 510(k) number K260063.

Who is the listed applicant for GSPE Spacer?

The FDA 510(k) record lists The General Hospital Corporation, d/b/a Massachusetts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSPE Spacer?

The FDA product code for GSPE Spacer is JWH.

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