Medical Device Manufacturer · US , Irvin , CA

Advanced Sterilization Products

54 submissions · 54 cleared · Since 1994
54
Total
54
Cleared
0
Denied

Advanced Sterilization Products — FDA 510(k) Submissions

Advanced Sterilization Products has submitted 54 FDA 510(k) premarket notifications since 1994, of which 54 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Indicator, Biological Sterilization Process, Sterilizer, Chemical, Indicator, Physical/chemical Sterilization Process, Sterilant, Medical Devices, Accessories, Cleaning, For Endoscope . Use the specialty filter in the sidebar to narrow results.

54 devices
1–25 of 54
STERRAD? 100NX Sterilizer with ALLClear? Technology and ULTRA GI? Cycle (10104); APTIMAX? Instrument Tray for ULTRA GI? Cycle (011077)
K234082 · MLR Sterilizer, Chemical · General Hospital
Jul 2024 196d
Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
K163598 · KCT Sterilization Wrap... · General Hospital
Jul 2017 222d
STERRAD NX Sterilizer
K162007 · MLR Sterilizer, Chemical · General Hospital
Feb 2017 211d
STERRAD? NX Sterilizer with ALLClear? Technology
K160818 · MLR Sterilizer, Chemical · General Hospital
Sep 2016 187d
STERRAD 100NX Sterilizer with ALLClearTM Technology
K160903 · MLR Sterilizer, Chemical · General Hospital
Sep 2016 178d
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
K151725 · MLR Sterilizer, Chemical · General Hospital
Jan 2016 201d
STERRAD CYCLESURE 24 Biological Indicator
K151971 · FRC Indicator, Biological... · General Hospital
Oct 2015 105d
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
K142454 · MLR Sterilizer, Chemical · General Hospital
Apr 2015 213d
EVOTECH ECR
K140977 · FEB Accessories, Cleaning,... · General Hospital
Dec 2014 250d
Tyvek? Pouch/Roll with STERRAD? Chemical Indicator
K141693 · FRG Wrap, Sterilization · General Hospital
Dec 2014 178d
STERRAD 50/100S/200 TEST PACK
K130263 · FRC Indicator, Biological... · General Hospital
Mar 2014 417d
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324
K123017 · FRC Indicator, Biological... · General Hospital
Dec 2012 89d
TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
K112087 · KCT Sterilization Wrap... · General Hospital
Oct 2012 452d
STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
K122044 · FRC Indicator, Biological... · General Hospital
Oct 2012 84d
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
K111518 · JOJ Indicator,... · General Hospital
Oct 2012 489d
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
K111519 · JOJ Indicator,... · General Hospital
Oct 2012 489d
STERRAD (R) 100NX DUO CYCLE TEST PACK
K111391 · FRC Indicator, Biological... · General Hospital
Sep 2012 497d
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
K111375 · FRC Indicator, Biological... · General Hospital
Sep 2012 487d
STERRAD(R) 100NX STERILIZER DUO CYCLE
K111377 · MLR Sterilizer, Chemical · General Hospital
Sep 2012 486d
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
K103210 · FRG Wrap, Sterilization · General Hospital
Jun 2011 217d
STERRAD CHEMICAL INDICATOR STRIP
K103218 · JOJ Indicator,... · General Hospital
Apr 2011 151d
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K103219 · JOJ Indicator,... · General Hospital
Apr 2011 151d
STERRAD 100NX STERILIZER EXPRESS CYCLE
K092622 · MLR Sterilizer, Chemical · General Hospital
Mar 2011 555d
STERRAAD 100NX EXPRESS CYCLE TEST PACK
K092755 · FRC Indicator, Biological... · General Hospital
Feb 2011 534d
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · FRC Indicator, Biological... · General Hospital
Feb 2011 116d
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