STERIZONE VP4 Sterilizer
FDA 510(k) clearance K153392 · decided 2016-03-24
Clearance details
- K-number
- K153392
- Device name
- STERIZONE VP4 Sterilizer
- Applicant
- Ts03, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-24
- Decision date
- 2016-03-24
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- PJJ
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Quebec, CA
- 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 STERILIZER (K141163) | Tso3, Inc. | 2014-12-17 |
Recalls involving this device
No recalls on record reference this clearance.