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Weck Vista Optical Bladeless Laparoscopic Access Port

by Teleflexmedical, Inc. 510(k)

Active United States

510(k) K121380

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK121380 Date25 May 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1283-2014 FDA Class II initiated 11 Mar 2014
    • Terminated Z-1278-2014 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-1325-2014 FDA Class II initiated 11 Mar 2014

    Complaints of leakage of insufflation gas through the device.

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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