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Tigerpaw System II

by Laax, Inc.

510(k) K111064

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK111064 Date18 May 2011ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1461-2015 FDA Class I initiated 25 Mar 2015
    • Terminated Z-1462-2015 FDA Class I initiated 25 Mar 2015

    Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.

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  • Withdrawn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
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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