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Medical Devices / Submissions and Approvals

FDA Clears Advanced Sterilization’s Endoscope Reprocessor

May 2, 2019
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The FDA granted 510(k) clearance for Advanced Sterilization’s ASP Aeroflex, a device that automatically cleans and sterilizes endoscopes.

Endoscopes must be thoroughly disinfected before patient use, which normally involves manually measuring the disinfectant’s concentration during every reprocessing.

The Advanced Sterilization device can automatically clean and disinfect flexible endoscopes from multiple manufacturers in 22 minutes, eliminating the need to use manual test strips to measure the disinfectant’s concentration.

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