510(k) K142454 ยท MLR Sterilizer, Chemical
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Apr 3, 2015 |
| Received | Sep 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2017 | Advanced Sterilization Products STERRAD NX Sterilization System, Product Code: 10033, 10033-002 Terminated |
MLR | None listed |
| Aug 13, 2015 | Advanced Sterilization Products Wall Chart for STERRAD 100NX System, P/N 10104.
The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.