FDA 510(k)

PENTAX Medical Video Colonoscope (EC38-i20cWL)

N.º K: K242110 · 2025-01-03

Fecha de decisión2025-01-03

Código de productoFDF

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PENTAX Medical Video Colonoscope (EC38-i20cWL) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K242110. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PENTAX Medical Video Colonoscope (EC38-i20cWL)?

PENTAX Medical Video Colonoscope (EC38-i20cWL) is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Pentax of America, Inc.. The 510(k) number is K242110.

When did PENTAX Medical Video Colonoscope (EC38-i20cWL) receive FDA 510(k) clearance?

PENTAX Medical Video Colonoscope (EC38-i20cWL) received FDA 510(k) clearance on 2025-01-03, under 510(k) number K242110.

Who is the listed applicant for PENTAX Medical Video Colonoscope (EC38-i20cWL)?

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

What is the FDA product code for PENTAX Medical Video Colonoscope (EC38-i20cWL)?

The FDA product code for PENTAX Medical Video Colonoscope (EC38-i20cWL) is FDF.

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Fuente oficial

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