510(k) K023290 ยท FLF Sterilizer, Ethylene-Oxide Gas
STERRAD 50 & STERRAD 100S STERILIZERS
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Apr 3, 2003 |
| Received | Oct 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 50, Product Code 10114.
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reus Terminated |
FLF | None listed |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 100S, Product Code 10113.
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive re Terminated |
FLF | 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 |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD 50 Sterilization System, Product Code: 10050
The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms Terminated |
FLF | None listed |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD 100S Sterilization System, Product Code: 10101
The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorg Terminated |
FLF | None listed |
| Jun 15, 2009 | Advanced Sterilization Products STERRAD 50 Sterilization System Product Code 10050
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devi Terminated |
FLF | None listed |
| Nov 21, 2008 | Advanced Sterilization Products STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components.
The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to st Terminated |
MLR | None listed |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 100S Sterilization System, Product Code 10101
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 50 Sterilization System, Product Code 10050
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.