DeviceClearance

Product code PJJ— General Hospital

STERIZONE VP4 Sterilizer

Classification name
Two Or More Sterilant Sterilizer
Device class
Class 2
Regulation
21 CFR 880.6860
Advisory panel
General Hospital
Total cleared
6
First cleared
Most recent

FDA classification definition

“Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.”

— U.S. Food and Drug Administration, device classification record for product code PJJ under 21 CFR 880.6860, via openFDA

Market context for product code PJJ

FDA has cleared 6 devices under product code PJJ between 2014 and 2019, 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 PJJ

Recent clearances under product code PJJ

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