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Replacement Gastrostomy Tube

by Microvasive

510(k) K861323

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

21 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 NumberK861323 Date16 Dec 1986ClearedStatusActive

Recalls

21 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0204-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0196-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0201-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0202-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0191-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0195-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0199-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0187-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0186-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0203-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0194-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0190-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0192-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0188-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0193-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0205-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0185-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0197-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0200-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0189-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003
    • Terminated Z-0198-04 FDA Unclassified (pre-2012) initiated 14 Nov 2003

    An increase in reported balloon failures, which may result in tube displacement.

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  • Withdrawn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

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