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California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands

by California Medical Laboratories, Inc.

510(k) K982891

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982891 Date30 Sep 1998ClearedStatusActive

Recalls

10 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0649-2013 FDA Class II initiated 2 Nov 2012
    • Terminated Z-0650-2013 FDA Class II initiated 2 Nov 2012

    California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.

    • Terminated Z-2046-2009 FDA Unclassified (pre-2012) initiated 5 Feb 2008

    A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.

  • 4 recalls, same reason

    • Terminated Z-1313-2008 FDA Unclassified (pre-2012) initiated 29 Jan 2008 on shared 510(k) K982891
    • Terminated Z-1311-2008 FDA Unclassified (pre-2012) initiated 29 Jan 2008 on shared 510(k) K982891
    • Terminated Z-1310-2008 FDA Unclassified (pre-2012) initiated 29 Jan 2008 on shared 510(k) K982891
    • Terminated Z-1312-2008 FDA Unclassified (pre-2012) initiated 29 Jan 2008 on shared 510(k) K982891

    Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.

  • 3 recalls, same reason

    • Terminated Z-1176-2008 FDA Unclassified (pre-2012) initiated 24 Jan 2008
    • Terminated Z-1177-2008 FDA Unclassified (pre-2012) initiated 24 Jan 2008
    • Terminated Z-1175-2008 FDA Unclassified (pre-2012) initiated 24 Jan 2008

    Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

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
DTS
Device Class
Class II
Regulation
21 CFR Part 870.4420
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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