DeviceClearance

Product code HFB— Obstetrics/Gynecology

OWENS BIOPSY FORCEPS

Classification name
Forceps, Biopsy, Gynecological
Device class
Class 1
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
22
First cleared
Most recent

Market context for product code HFB

FDA has cleared 22 devices under product code HFB between 1981 and 2002, filed by 16 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code HFB

Recent clearances under product code HFB

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