Two Or More Sterilant Sterilizer
The Two or More Sterilant Sterilizer is a hospital sterilization device intended for terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in healthcare facilities using two or more sterilants. It is an FDA Class 2 device regulated under 21 CFR 880.6860, requiring 510(k) premarket notification, within the General Hospital (HO) medical specialty. The product code is PJJ. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PJJ
- Device Class
- FDA class 2
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190260 | STERIZONE(R) VP4 Sterilizer | Jul 19, 2019 | Substantially Equivalent | Tso3, Inc. |
| K172191 | STERIZONE VP4 Sterilizer | May 09, 2018 | Substantially Equivalent | Tso3, Inc. |
| K173694 | STERIZONE VP4 Sterilizer | Mar 13, 2018 | Substantially Equivalent | Tso3, Inc. |
| K153689 | STERIZONE Sterilizer | Jun 30, 2016 | Substantially Equivalent | Tso3, Inc. |
| K153392 | STERIZONE VP4 Sterilizer | Mar 24, 2016 | Substantially Equivalent | Ts03, Inc. |
| K141163 | STERIZONE STERILIZER | Dec 17, 2014 | Substantially Equivalent | Tso3, Inc. |