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Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set

by Xeridiem (Formerly Mri)

510(k) K142297

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

100 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 NumberK142297 Date8 Jan 2015ClearedStatusActive

Recalls

100 recalls · FDA

  • 100 recalls, same reason

    • Terminated Z-0958-2016 FDA Class II initiated 23 Dec 2015
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    A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

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  • Withdrawn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
PIF
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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