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Speculum, Vaginal, Nonmetal

by Welch Allyn, Inc.

510(k) K120743

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120743 Date23 Mar 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0169-2016 FDA Class II initiated 2 Oct 2015

    The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard.

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  • Withdrawn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
HIB
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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