STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
FDA 510(k) clearance K142454 · decided 2015-04-03
Clearance details
- K-number
- K142454
- Device name
- STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2014-09-02
- Decision date
- 2015-04-03
- Days to decision
- 213 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 |
| Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed f recall (Z-2375-2015) | Advanced Sterilization Products | 2015-08-13 |