FDA 510(k)

SurgiCount+ System

Número K: K252282 · 2026-03-16

Data da decisão2026-03-16

Código do produtoPBZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SurgiCount+ System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K252282. The device is classified under product code PBZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SurgiCount+ System?

SurgiCount+ System is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Stryker Instruments. The 510(k) number is K252282.

When did SurgiCount+ System receive FDA 510(k) clearance?

SurgiCount+ System received FDA 510(k) clearance on 2026-03-16, under 510(k) number K252282.

Who is the listed applicant for SurgiCount+ System?

The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiCount+ System?

The FDA product code for SurgiCount+ System is PBZ.

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Fonte oficial

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