Rigid Sterilization Container With Software
The Rigid Sterilization Container With Software is a Class 2 general hospital device intended to enclose medical devices for sterilization by a healthcare provider, maintaining sterility of the enclosed devices until use, and designed for use with high-vacuum or pulse-vacuum steam sterilization systems. It requires 510(k) clearance and is regulated under 21 CFR 880.6855 within the General Hospital medical specialty. The product code is QJT. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QJT
- Device Class
- FDA class 2
- Regulation Number
- 880.6855
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN210004 | Zuno Smart Sterilization Container | Jun 17, 2022 | Unknown | Zuno Medical, Inc. |