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Adapt(Tm) Universal Balloon Open Access Port

by Teleflexmedical, Inc.

510(k) K112456

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 · Special NumberK112456 Date4 Oct 2011ClearedStatusActive

Recalls

6 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1289-2014 FDA Class II initiated 11 Mar 2014
    • Terminated Z-1290-2014 FDA Class II initiated 11 Mar 2014
    • Terminated Z-1287-2014 FDA Class II initiated 11 Mar 2014
    • Terminated Z-1288-2014 FDA Class II initiated 11 Mar 2014
    • Terminated Z-1286-2014 FDA Class II initiated 11 Mar 2014

    Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

    • Terminated Z-1328-2014 FDA Class II initiated 11 Mar 2014

    Complaints of leakage of insufflation gas through the device.

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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