Atraumatic Tenacula

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K891033 ↗

FDA Product Code

HDC

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Scissors: Thorek, Jorgensen, Finochietto

  Class I

  FDA 510(k) K891203 Active Cleared 6 Apr 1989

• Zeppelin Scissors

  Class I

  FDA 510(k) K891049 Active Cleared 17 Mar 1989

• Rectal Specula - Chelsea-Eaton, Kelly, Mathieu

  Class I

  FDA 510(k) K892542 Active Cleared 9 May 1989

• Zsi Biopsy Forceps

  Class I

  FDA 510(k) K891027 Active Cleared 17 Mar 1989

• Dental Root Elevator

  Class II

  FDA 510(k) K892255 Active Cleared 1 May 1989

• Vaginal Retractors - Kristeller, Delee, Breisky

  Class I

  FDA 510(k) K891038 Active Cleared 17 Mar 1989

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