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Medivators Advantage Plus Endoscope Reprocessor

by Medivators Reprocessing Systems

510(k) K102996

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

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 NumberK102996 Date13 Jan 2011ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2538-2024 FDA Class II initiated 13 Jun 2024
    • Ongoing Z-2536-2024 FDA Class II initiated 13 Jun 2024
    • Ongoing Z-2537-2024 FDA Class II initiated 13 Jun 2024

    IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection

    • Ongoing Z-0617-2024 FDA Class II initiated 13 Nov 2023

    Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

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  • Withdrawn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
FEB
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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