STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
FDA 510(k) clearance K151725 · decided 2016-01-13
Clearance details
- K-number
- K151725
- Device name
- STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2015-06-26
- Decision date
- 2016-01-13
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- MLR
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STERRAD NX Sterilization System, Product Code: 10033, 10033-002 recall (Z-1197-2017) | Advanced Sterilization Products | 2017-02-14 |