Advanced Sterilization Products - FDA 510(k) Cleared Devices

Cleared Jan 28, 2011

STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR

K102884 · FRC

General Hospital · 120d

Cleared Nov 13, 2008

EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR

K082392 · FEB

General Hospital · 86d

Cleared Dec 18, 2007

STERRAD 100NX TEST PACK

K071537 · FRC

General Hospital · 196d

Cleared Nov 29, 2007

STERRAD 100NX STERILIZER

K071385 · MLR

General Hospital · 195d

Cleared May 24, 2007

MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR

K071014 · FRC

General Hospital · 44d

Cleared Oct 26, 2006

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM

K061899 · FEB

General Hospital · 115d

Cleared Aug 19, 2005

STERRAD STERILIZER CYCLESURE TEST PACK

K051643 · FRC

General Hospital · 60d

Cleared May 12, 2005

STERRAD NX CHALLENGE PACK

K042450 · FRC

General Hospital · 245d

Cleared Apr 22, 2005

STERRAD NX STERILIZER

K042116 · MLR

General Hospital · 260d

Cleared Apr 04, 2005

CIDEX OPA CONCENTRATE

K032959 · MED

General Hospital · 559d

Cleared Mar 15, 2005

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM

K040883 · FEB

General Hospital · 344d

Cleared Apr 02, 2004

MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE

K040742 · JOJ

General Hospital · 10d

Cleared Aug 18, 2003

STERRAD 200 STERILIZER

K030429 · MLR

General Hospital · 189d

Cleared May 02, 2003

STERRAD CYCLESURE BIOLOGICAL INDICATOR

K031226 · FRC

General Hospital · 14d

Cleared Apr 03, 2003

STERRAD 50 & STERRAD 100S STERILIZERS

K023290 · FLF

General Hospital · 183d

Cleared Feb 27, 2003

0.55% ORTH-PHTHALALDEHYDE SOLUTION

K030004 · MED

General Hospital · 56d

Cleared Oct 08, 2002

STERRAD SEALSURE CHEMICAL INDICATOR TAPE

K022441 · JOJ

General Hospital · 75d

Cleared Aug 28, 2002

APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER

K013003 · FRG

General Hospital · 356d

Cleared Feb 13, 2002

STERRAD CYCLESURE BIOLOGICAL INDICATOR

K994055 · FRC

General Hospital · 806d

Cleared Aug 29, 2000

CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)

K002401 · MED

General Hospital · 22d

Cleared Jun 15, 2000

STERRAD 100S STERILIZER

K991999 · MLR

General Hospital · 367d

Cleared Jun 01, 2000

STERRAD BI TEST PACK

K993775 · FRC

General Hospital · 206d

Cleared May 17, 2000

CIDEX OPA SOLUTION

K001381 · MED

General Hospital · 15d

Cleared Oct 08, 1999

CIDEX OPA SOLUTION

K991487 · MED

General Hospital · 163d

Cleared Jun 15, 1999

MODIFICATION OF: STERRAD BI TEST PACK

K991675 · FRC

General Hospital · 29d