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Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter

by Portex, Ltd.

510(k) K033084

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 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033084 Date19 Dec 2003ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1240-2013 FDA Class II initiated 28 Mar 2013
    • Terminated Z-1239-2013 FDA Class II initiated 28 Mar 2013
    • Terminated Z-1244-2013 FDA Class II initiated 28 Mar 2013
    • Terminated Z-1243-2013 FDA Class II initiated 28 Mar 2013
    • Terminated Z-1241-2013 FDA Class II initiated 28 Mar 2013
    • Terminated Z-1242-2013 FDA Class II initiated 28 Mar 2013

    Unable to pass catheter through outer sheath during embryo transfer

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  • Withdrawn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
MQF
FDA applicant
Portex , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.6110
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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