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EXALT Model D Single-Use Duodenoscope, EXALT Controller

by Boston Scientific

510(k) K193202

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193202 Date13 Dec 2019ClearedStatusActive

Recalls

6 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0397-2024 FDA Class II initiated 27 Sep 2023
    • Ongoing Z-0396-2024 FDA Class II initiated 27 Sep 2023

    Poor image quality due to fluid ingress in the lens.

  • 4 recalls, same reason

    • Ongoing Z-1081-2022 FDA Class II initiated 3 Mar 2022
    • Ongoing Z-1082-2022 FDA Class II initiated 3 Mar 2022
    • Ongoing Z-1079-2022 FDA Class II initiated 3 Mar 2022
    • Ongoing Z-1080-2022 FDA Class II initiated 3 Mar 2022

    Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

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  • Withdrawn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
FDT
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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