510(k) K991999 ยท MLR Sterilizer, Chemical
STERRAD 100S STERILIZER
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Jun 15, 2000 |
| Received | Jun 14, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991999
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2012 | Advanced Sterilization Products STERRAD 100S Cassette, Batch # 12A077.
The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable me Terminated |
MLR | 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 |
| Feb 8, 2008 | Advanced Sterilization Products STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA 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 |
| Nov 24, 2005 | Advanced Sterilization Products Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.