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Bravo Ph Monitoring System

by Endonetics, Inc.

510(k) K002028

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK002028 Date29 Sep 2000ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1620-2016 FDA Class II initiated 15 Apr 2016
    • Terminated Z-1619-2016 FDA Class II initiated 15 Apr 2016

    Potential of an allergic reaction in a patient with nickel sensitivity.

    • Terminated Z-0517-2008 FDA Unclassified (pre-2012) initiated 3 Dec 2007

    Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.

    • Terminated Z-0633-04 FDA Unclassified (pre-2012) initiated 6 Feb 2004 on shared 510(k) K002028

    The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
FFT
Device Class
Class I
Regulation
21 CFR Part 876.1400
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent