510(k) DEN210004
DEN210004 is an FDA 510(k) premarket notification submitted by Zuno Medical, Inc. for the device "Zuno Smart Sterilization Container". The FDA issued a decision of De Novo Granted on June 17, 2022. The device falls under product code QJT (Rigid Sterilization Container With Software), a Class II device regulated under 21 CFR 880.6855.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 17, 2022
- Date Received
- February 16, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rigid Sterilization Container With Software
- Device Class
- Class II
- Regulation Number
- 880.6855
- Review Panel
- HO
- Submission Type
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.