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Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit

by Boston Scientific

510(k) K031538

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 · Special NumberK031538 Date27 Jun 2003ClearedStatusActive

Recalls

21 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1517-2024 FDA Class II initiated 20 Feb 2024
    • Ongoing Z-1515-2024 FDA Class II initiated 20 Feb 2024
    • Ongoing Z-1516-2024 FDA Class II initiated 20 Feb 2024

    Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration

  • 12 recalls, same reason

    • Terminated Z-1629-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-1628-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-1626-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-1627-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-1631-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-1632-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-1630-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-1625-2009 FDA Unclassified (pre-2012) initiated 5 May 2009
    • Terminated Z-0914-2009 FDA Unclassified (pre-2012) initiated 30 Dec 2008
    • Terminated Z-0911-2009 FDA Unclassified (pre-2012) initiated 30 Dec 2008
    • Terminated Z-0913-2009 FDA Unclassified (pre-2012) initiated 30 Dec 2008
    • Terminated Z-0912-2009 FDA Unclassified (pre-2012) initiated 30 Dec 2008

    The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.

  • 6 recalls, same reason

    • Terminated Z-0965-05 FDA Unclassified (pre-2012) initiated 2 Jun 2005 on shared 510(k) K031538
    • Terminated Z-0966-05 FDA Unclassified (pre-2012) initiated 2 Jun 2005 on shared 510(k) K031538
    • Terminated Z-0963-05 FDA Unclassified (pre-2012) initiated 2 Jun 2005 on shared 510(k) K031538
    • Terminated Z-0967-05 FDA Unclassified (pre-2012) initiated 2 Jun 2005
    • Terminated Z-0964-05 FDA Unclassified (pre-2012) initiated 2 Jun 2005 on shared 510(k) K031538
    • Terminated Z-0968-05 FDA Unclassified (pre-2012) initiated 2 Jun 2005

    Two blades may be heat staked onto the stiletto instead of the expected one blade.

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
KNT
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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