DeviceClearance

Product code QJT— General Hospital

Zuno Smart Sterilization Container

Classification name
Rigid Sterilization Container With Software
Device class
Class 2
Regulation
21 CFR 880.6855
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility until used. The rigid sterilization container with software is designed for use with high-vacuum or pulse-vacuum steam sterilization systems.”

— U.S. Food and Drug Administration, device classification record for product code QJT under 21 CFR 880.6855, via openFDA

Market context for product code QJT

FDA has cleared 1 device under product code QJT, all in 2022, 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 QJT

Recent clearances under product code QJT

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