Skip to content

Endoeye Hd II

by Olympus America, Inc.

510(k) K111788

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111788 Date13 Jan 2012ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1929-2017 FDA Class II initiated 10 Feb 2017

    A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.

    • Terminated Z-0403-2016 FDA Class II initiated 17 Nov 2015

    A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.

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  • Withdrawn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
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from Olympus America, Inc.

See all devices from Olympus America, Inc. →