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Morton Iui Catheters

by Fertility Technology Resources, Inc. 510(k)

Active United States

510(k) K041470

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041470 Date22 Nov 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0663-2008 FDA Unclassified (pre-2012) initiated 13 Sep 2007

    Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

Specification

510(k)

510(k) Number
FDA Product Code
MQF
Device Class
Class II
Regulation
21 CFR Part 884.6110
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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