STERIZONE STERILIZER
FDA 510(k) clearance K141163 · decided 2014-12-17
Clearance details
- K-number
- K141163
- Device name
- STERIZONE STERILIZER
- Applicant
- Tso3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-05
- Decision date
- 2014-12-17
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- PJJ
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Vancouver, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STERIZONE(R) VP4 Sterilizer (K190260) | Tso3, Inc. | 2019-07-19 |
| STERIZONE VP4 Sterilizer (K172191) | Tso3, Inc. | 2018-05-09 |
| STERIZONE VP4 Sterilizer (K173694) | Tso3, Inc. | 2018-03-13 |
| STERIZONE Sterilizer (K153689) | Tso3, Inc. | 2016-06-30 |
| STERIZONE VP4 Sterilizer (K153392) | Ts03, Inc. | 2016-03-24 |
Recalls involving this device
No recalls on record reference this clearance.