Product code FHJ— Obstetrics/Gynecology

SAFEBRIS STERILE CIRCUMCISION KIT

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

Market context for product code FHJ

FDA has cleared 2 devices under product code FHJ between 1983 and 1990, filed by 2 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 FHJ

Recent clearances under product code FHJ

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