DeviceClearance

Product code HDC— Obstetrics/Gynecology

ATRAUMATIC TENACULA

Classification name
Tenaculum, Uterine
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
20
First cleared
Most recent

Market context for product code HDC

FDA has cleared 20 devices under product code HDC between 1989 and 2023, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HDC

Recent clearances under product code HDC

Data sourced from openFDA. This site is unofficial and independent of the FDA.