Product code HHJ— Obstetrics/Gynecology

USG 2000SA

Classification name
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
Device class
Class 2
Regulation
21 CFR 884.2225
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

Market context for product code HHJ

FDA has cleared 1 device under product code HHJ, all in 2002, 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 HHJ

Recent clearances under product code HHJ

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