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Automated Endoscope Leak Tester

by Olympus Medical Systems Corp.

510(k) K123704

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123704 Date4 Feb 2013ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PCV
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Automated Endoscope Leak Tester is an endoscopic leak tester designed to detect leaks in flexible endoscopes. It performs automated leakage testing to identify potential breaches in the device integrity before or after clinical use.

This device is operated by connecting leak test air tubes to the endoscope venting connector. It is intended for use in a clinical setting and requires the user to ensure the endoscope connector is free of water, dust, or debris prior to operation. The device is regulated under FDA 510K clearance.

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