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Flexible Intubation Video Endoscope – Sterile (FIVE-S)

by Karl Storz Endoscopy America

510(k) K212656

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK212656 Date29 Dec 2021ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2589-2023 FDA Class II initiated 7 Jul 2023

    Flexible intubation endoscopes sterility assurance can not be confirmed.

    • Ongoing Z-1055-2022 FDA Class II initiated 1 Apr 2022

    Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

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  • Withdrawn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
EOQ
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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