Product code HFK— Obstetrics/Gynecology

MEDSURG CIRCUMCISION TRAY

Classification name
Mold, Vaginal
Device class
Class 2
Regulation
21 CFR 884.3900
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

Market context for product code HFK

FDA has cleared 1 device under product code HFK, all in 1993, filed by 1 applicant company. 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.

Top applicants under product code HFK

Recent clearances under product code HFK

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