FDA 510(k) Applications Submitted by ADVANCED STERILIZATION PRODUCTS

FDA 510(k) Number Submission Date Device Name Applicant
K160818 03/24/2016 STERRAD« NX Sterilizer with ALLClearÖ Technology ADVANCED STERILIZATION PRODUCTS
K160903 04/01/2016 STERRAD 100NX Sterilizer with ALLClearTM Technology ADVANCED STERILIZATION PRODUCTS
K991487 04/28/1999 CIDEX OPA SOLUTION ADVANCED STERILIZATION PRODUCTS
K082392 08/19/2008 EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR ADVANCED STERILIZATION PRODUCTS
K051643 06/20/2005 STERRAD STERILIZER CYCLESURE TEST PACK ADVANCED STERILIZATION PRODUCTS
K061899 07/03/2006 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS
K042450 09/09/2004 STERRAD NX CHALLENGE PACK ADVANCED STERILIZATION PRODUCTS
K040742 03/23/2004 MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS
K981625 05/07/1998 STERRAD 50 STERILIZER ADVANCED STERILIZATION PRODUCTS
K991675 05/17/1999 MODIFICATION OF: STERRAD BI TEST PACK ADVANCED STERILIZATION PRODUCTS
K991999 06/14/1999 STERRAD 100S STERILIZER ADVANCED STERILIZATION PRODUCTS
K954142 09/01/1995 STERRADD STERILIZATION SYSTEM ADVANCED STERILIZATION PRODUCTS
K102884 09/30/2010 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS
K993775 11/08/1999 STERRAD BI TEST PACK ADVANCED STERILIZATION PRODUCTS
K994055 11/30/1999 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS
K130263 02/04/2013 STERRAD 50/100S/200 TEST PACK ADVANCED STERILIZATION PRODUCTS
K111377 05/16/2011 STERRAD(R) 100NX STERILIZER DUO CYCLE ADVANCED STERILIZATION PRODUCTS
K111375 05/16/2011 STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS
K111391 05/18/2011 STERRAD (R) 100NX DUO CYCLE TEST PACK ADVANCED STERILIZATION PRODUCTS
K111519 06/02/2011 STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 ADVANCED STERILIZATION PRODUCTS
K111518 06/02/2011 STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 ADVANCED STERILIZATION PRODUCTS
K122044 07/12/2012 STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS
K112087 07/21/2011 TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS ADVANCED STERILIZATION PRODUCTS
K092622 08/26/2009 STERRAD 100NX STERILIZER EXPRESS CYCLE ADVANCED STERILIZATION PRODUCTS
K092755 09/09/2009 STERRAAD 100NX EXPRESS CYCLE TEST PACK ADVANCED STERILIZATION PRODUCTS
K123017 09/28/2012 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 ADVANCED STERILIZATION PRODUCTS
K103219 11/01/2010 STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS
K103218 11/01/2010 STERRAD CHEMICAL INDICATOR STRIP ADVANCED STERILIZATION PRODUCTS
K103210 11/01/2010 TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS ADVANCED STERILIZATION PRODUCTS
K030429 02/10/2003 STERRAD 200 STERILIZER ADVANCED STERILIZATION PRODUCTS
K031226 04/18/2003 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS
K022441 07/25/2002 STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS
K042116 08/05/2004 STERRAD NX STERILIZER ADVANCED STERILIZATION PRODUCTS
K013003 09/06/2001 APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER ADVANCED STERILIZATION PRODUCTS
K023290 10/02/2002 STERRAD 50 & STERRAD 100S STERILIZERS ADVANCED STERILIZATION PRODUCTS
K162007 07/20/2016 STERRAD NX Sterilizer Advanced Sterilization Products
K163598 12/21/2016 Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator ADVANCED STERILIZATION PRODUCTS
K030004 01/02/2003 0.55% ORTH-PHTHALALDEHYDE SOLUTION ADVANCED STERILIZATION PRODUCTS
K040883 04/05/2004 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS
K001381 05/02/2000 CIDEX OPA SOLUTION ADVANCED STERILIZATION PRODUCTS
K032959 09/23/2003 CIDEX OPA CONCENTRATE ADVANCED STERILIZATION PRODUCTS
K002401 08/07/2000 CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) ADVANCED STERILIZATION PRODUCTS
K140977 04/16/2014 EVOTECH ECR ADVANCED STERILIZATION PRODUCTS
K071385 05/18/2007 STERRAD 100NX STERILIZER ADVANCED STERILIZATION PRODUCTS
K071537 06/05/2007 STERRAD 100NX TEST PACK ADVANCED STERILIZATION PRODUCTS
K141693 06/24/2014 Tyvek« Pouch/Roll with STERRAD« Chemical Indicator ADVANCED STERILIZATION PRODUCTS
K151725 06/26/2015 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS
K151971 07/16/2015 STERRAD CYCLESURE 24 Biological Indicator ADVANCED STERILIZATION PRODUCTS
K142454 09/02/2014 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS
K071014 04/10/2007 MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS
K103222 11/01/2010 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS


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