Skip to content

Lofric Primo, Lofric Hydro-Kit

by Astra Tech, Inc.

510(k) K122078

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK122078 Date31 Oct 2012ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2643-2020 FDA Class II initiated 17 Jun 2020

    Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.

  • 2 recalls, same reason

    • Terminated Z-2644-2020 FDA Class II initiated 17 Jun 2020
    • Terminated Z-2645-2020 FDA Class II initiated 17 Jun 2020

    Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.

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  • Withdrawn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
EZD
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Astra Tech, Inc.

See all devices from Astra Tech, Inc. →