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Bifurcated Suction/Irrigat Tubing Set W/Push Butto

by Core Dynamics, Inc.

510(k) K926477

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK926477 Date12 Nov 1993ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0134-2017 FDA Class II initiated 27 Jun 2016
    • Terminated Z-0135-2017 FDA Class II initiated 27 Jun 2016
    • Terminated Z-0130-2017 FDA Class II initiated 27 Jun 2016
    • Terminated Z-0132-2017 FDA Class II initiated 27 Jun 2016
    • Terminated Z-0129-2017 FDA Class II initiated 27 Jun 2016
    • Terminated Z-0133-2017 FDA Class II initiated 27 Jun 2016

    The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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  • Withdrawn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
GBW
Device Class
Class I
Regulation
21 CFR Part 878.4200
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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