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Vci Suction/Irrigation Tubing Set

by Vital Concepts, Inc.

510(k) K934382

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 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 NumberK934382 Date1 Feb 1994ClearedStatusActive

Recalls

10 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0258-04 FDA Unclassified (pre-2012) initiated 7 Nov 2003 on shared 510(k) K934382
    • Terminated Z-0260-04 FDA Unclassified (pre-2012) initiated 7 Nov 2003 on shared 510(k) K934382
    • Terminated Z-0261-04 FDA Unclassified (pre-2012) initiated 7 Nov 2003 on shared 510(k) K934382
    • Terminated Z-0259-04 FDA Unclassified (pre-2012) initiated 7 Nov 2003 on shared 510(k) K934382

    The probe may separate from the cannula.

  • 6 recalls, same reason

    • Terminated Z-0020-04 FDA Unclassified (pre-2012) initiated 11 Jul 2003 on shared 510(k) K934382
    • Terminated Z-0021-04 FDA Unclassified (pre-2012) initiated 11 Jul 2003 on shared 510(k) K934382
    • Terminated Z-0023-04 FDA Unclassified (pre-2012) initiated 11 Jul 2003 on shared 510(k) K934382
    • Terminated Z-0022-04 FDA Unclassified (pre-2012) initiated 11 Jul 2003 on shared 510(k) K934382
    • Terminated Z-0024-04 FDA Unclassified (pre-2012) initiated 11 Jul 2003 on shared 510(k) K934382
    • Terminated Z-0025-04 FDA Unclassified (pre-2012) initiated 11 Jul 2003 on shared 510(k) K934382

    The suction valve may become stuck in the 'suction on' position under vacuum.

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  • Withdrawn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
JOL
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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