Advanced Sterilization Products

FDA 510(k) & PMA Approved Devices — 49 products

Total Devices49

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K234082	STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)	MLR	2024-07-05	View
510(k)	K163598	Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator	KCT	2017-07-31	View
510(k)	K162007	STERRAD NX Sterilizer	MLR	2017-02-16	View
510(k)	K160818	STERRAD® NX Sterilizer with ALLClear™ Technology	MLR	2016-09-27	View
510(k)	K160903	STERRAD 100NX Sterilizer with ALLClearTM Technology	MLR	2016-09-26	View
510(k)	K151725	STERRAD NX Sterilizer, STERRAD 100NX Sterilizer	MLR	2016-01-13	View
510(k)	K123017	STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324	FRC	2012-12-26	View
510(k)	K112087	TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS	KCT	2012-10-15	View
510(k)	K122044	STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR	FRC	2012-10-04	View
510(k)	K111518	STERRAD CHEMIAL INDICATOR STRIP MODEL 14100	JOJ	2012-10-03	View
510(k)	K111519	STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202	JOJ	2012-10-03	View
510(k)	K111391	STERRAD (R) 100NX DUO CYCLE TEST PACK	FRC	2012-09-26	View
510(k)	K111375	STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR	FRC	2012-09-14	View
510(k)	K111377	STERRAD(R) 100NX STERILIZER DUO CYCLE	MLR	2012-09-13	View
510(k)	K103210	TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS	FRG	2011-06-06	View
510(k)	K103218	STERRAD CHEMICAL INDICATOR STRIP	JOJ	2011-04-01	View
510(k)	K103219	STERRAD SEALSURE CHEMICAL INDICATOR TAPE	JOJ	2011-04-01	View
510(k)	K092622	STERRAD 100NX STERILIZER EXPRESS CYCLE	MLR	2011-03-04	View
510(k)	K103222	STERRAD CYCLESURE BIOLOGICAL INDICATOR	FRC	2011-02-25	View
510(k)	K092755	STERRAAD 100NX EXPRESS CYCLE TEST PACK	FRC	2011-02-25	View