FDA 510(k)

Strauss Surgical cystoscope, hysteroscope and accessories Instruments

Número K: K260271 · 2026-03-27

RequerenteAmerican Medical Endoscopy, Inc.

Data da decisão2026-03-27

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Endoscopy, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K260271. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is American Medical Endoscopy, Inc.. The 510(k) number is K260271.

When did Strauss Surgical cystoscope, hysteroscope and accessories Instruments receive FDA 510(k) clearance?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260271.

Who is the listed applicant for Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

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

What is the FDA product code for Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

The FDA product code for Strauss Surgical cystoscope, hysteroscope and accessories Instruments is FAJ.

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Dispositivos Relacionados (Código: FAJ)

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