FDA 510(k)

Sistema de Imagem Portátil e Mão na Mão de 780 nm SPY (SPY-PHI)

Número K: K261037 · 2026-05-28

Data da decisão2026-05-28

Código do produtoIZI

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

780 nm SPY Portable Handheld Imaging (SPY-PHI) System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K261037. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?

780 nm SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Stryker Endoscopy. The 510(k) number is K261037.

When did 780 nm SPY Portable Handheld Imaging (SPY-PHI) System receive FDA 510(k) clearance?

780 nm SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K261037.

Who is the listed applicant for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?

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

What is the FDA product code for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?

The FDA product code for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System is IZI.

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