Ecn Electronic Video Cystonephroscope

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030960 ↗

FDA Product Code

FAJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the ECN Electronic Video Cystonephroscope used for?

  This device is a flexible endoscopic surgical video system intended for use in both urological and gastroenterological procedures to provide visualization during clinical interventions.

• What are the main components of this system?

  The system consists of a flexible endoscope equipped with an integrated light source and a CMOS video sensor, which is designed to be paired with a dedicated controller unit for operation.

• What is the regulatory classification of this device?

  The ECN Electronic Video Cystonephroscope is classified as a Class 2 cystoscope and accessories under regulation 876.1500. It received FDA 510(k) clearance on July 16, 2003, via the traditional pathway.