510(k) K042116 ยท MLR Sterilizer, Chemical
STERRAD NX STERILIZER
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Apr 22, 2005 |
| Received | Aug 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042116
| 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 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD NX, Product Code 10133
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusa Terminated |
MLR | None listed |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD NX Sterilization System, Product Code: 10033
The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganism Terminated |
MLR | None listed |
| Nov 26, 2013 | Advanced Sterilization Products STERRAD NX, Product Code: 10033
The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Sep 7, 2012 | Advanced Sterilization Products STERRAD NX Cassette, Batch # 12A078.
The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medi Terminated |
MLR | None listed |
| Jan 11, 2012 | Advanced Sterilization Products STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133.
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture Terminated |
MLR | None listed |
| Jun 15, 2009 | Advanced Sterilization Products STERRAD NX Sterilization System Product Code 10033
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devi Terminated |
MLR | None listed |
| Dec 2, 2008 | Advanced Sterilization Products STERRAD NX Sterilizer, Product Code 10033
Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments. Terminated |
MLR | None listed |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD NX Sterilizer, Product Code 10033
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Feb 7, 2008 | Advanced Sterilization Products STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.