Medical Device Manufacturer · US , Irvin , CA

Advanced Sterilization Products - FDA 510(k) Cleared Devices

54 submissions · 54 cleared · Since 1994

Recent clearances: STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104), Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator, STERRAD NX Sterilizer

View 54 510(k) Devices ↓

54

Total

54

Cleared

0

Denied

FDA 510(k) Regulatory Record - Advanced Sterilization Products General Hospital ✕

54 devices

1-12 of 54

Cleared Jul 05, 2024

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)

General Hospital · 196d

Cleared Jul 31, 2017

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with...

General Hospital · 222d

Cleared Feb 16, 2017

STERRAD NX Sterilizer

General Hospital · 211d

Cleared Sep 27, 2016

STERRAD® NX Sterilizer with ALLClear™ Technology

General Hospital · 187d

Cleared Sep 26, 2016

STERRAD 100NX Sterilizer with ALLClearTM Technology

General Hospital · 178d

Cleared Jan 13, 2016

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

General Hospital · 201d

Cleared Oct 29, 2015

STERRAD CYCLESURE 24 Biological Indicator

General Hospital · 105d

Cleared Apr 03, 2015

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

General Hospital · 213d

Cleared Dec 22, 2014

General Hospital · 250d

Cleared Dec 19, 2014

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

General Hospital · 178d

Cleared Mar 28, 2014

STERRAD 50/100S/200 TEST PACK

General Hospital · 417d

Cleared Dec 26, 2012

STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324

General Hospital · 89d

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