QJT — Rigid Sterilization Container With Software Class II
FDA product code QJT covers "Rigid Sterilization Container With Software", a Class II medical device regulated under 21 CFR 880.6855. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QJT
- Device Class
- Class II
- Regulation Number
- 880.6855
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210004 | zuno medical | Zuno Smart Sterilization Container | June 17, 2022 |