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Wallace Artificial Insemination Catheter - 8cm/18cm

by Marlow Surgical Technologies, Inc.

510(k) K964848

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964848 Date16 Jan 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1713-2020 FDA Class III initiated 28 Feb 2020

    Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.

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  • Withdrawn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
MFD
Device Class
Class II
Regulation
21 CFR Part 884.5250
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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