DEN210004 is an FDA 510(k) submission for the Zuno Smart Sterilization Container. This device is classified as a Rigid Sterilization Container With Software (Class II - Special Controls, product code QJT).
Submitted by Zuno Medical, Inc. (Campbell, US). The FDA issued a Not Cleared (DENG) decision on June 17, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6855. 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..
| 510(k) Number | DEN210004 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 16, 2021 |
| Decision Date | June 17, 2022 |
| Days to Decision | 486 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QJT - Rigid Sterilization Container With Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6855 |
| 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. |