Sedlacek Handle

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K926179 ↗

FDA Product Code

HGI

Device Class

Class II

Regulation

21 CFR Part 884.4120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Hand Mirror (Endoscope)

  Class II

  FDA 510(k) K862717 Active Cleared 30 Jul 1986

• Mi-Mark Endocervical Sampling Set

  Class II

  FDA 510(k) K790923 Active Cleared 22 Jun 1979

• Sexual Assault Forencic Evidence Kit

  Class I

  FDA 510(k) K772298 Active Cleared 2 Mar 1978

• Newport Cervical Manipulator

  Class II

  FDA 510(k) K891350 Active Cleared 29 Mar 1989

• Surgical Laser Accessories (Sla) Case

  Class I

  FDA 510(k) K862629 Active Cleared 17 Jul 1986

• Campion Cervical Hook

  Class II

  FDA 510(k) K891349 Active Cleared 29 Mar 1989

See all devices from Simpson/Basye, Inc. →

• What is the primary function of the Sedlacek Handle?

  The Sedlacek Handle is designed to serve as a gynecologic electrocautery accessory. It functions as a component within gynecologic surgical systems to facilitate electrocautery procedures.

• Is the Sedlacek Handle regulated by the FDA?

  Yes, the Sedlacek Handle is regulated under 21 CFR 884.4120 and has received FDA 510(k) clearance. This indicates that the device has been reviewed and cleared for market entry by the FDA.

• Which medical specialty is this device intended for?

  The Sedlacek Handle is categorized under the Obstetrics and Gynecology medical specialty, as it is specifically designed for use in gynecologic surgical systems.