ClearanceBrief
510(k) K042116 ยท MLR Sterilizer, Chemical

STERRAD NX STERILIZER

ApplicantAdvanced Sterilization Products, Irvin CA, US
DecisionSubstantially Equivalent, Apr 22, 2005
ReceivedAug 5, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K042116

DateFirm and productCodeLinked 510(k)
Feb 14, 2017Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Terminated
MLRNone listed
Dec 22, 2014Advanced 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
MLRNone listed
Jan 14, 2014Advanced 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
MLRNone listed
Nov 26, 2013Advanced 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
MLRNone listed
Sep 7, 2012Advanced 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
MLRNone listed
Jan 11, 2012Advanced 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
MLRNone listed
Jun 15, 2009Advanced 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
MLRNone listed
Dec 2, 2008Advanced 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
MLRNone listed
Aug 8, 2008Advanced Sterilization Products
STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRNone listed
Feb 7, 2008Advanced 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
MLRNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.