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FDA 510(k)

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor

K-Number: K181472 · 2019-04-23

ApplicantAdvanced Sterilization Products (Asp)
Decision Date2019-04-23
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is a medical device manufactured by Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2019-04-23 under approval number K181472. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is a medical device that received FDA 510(k) clearance on 2019-04-23. It is manufactured by Advanced Sterilization Products (Asp). The 510(k) number is K181472.

When was AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor approved by the FDA?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor received FDA 510(k) clearance on 2019-04-23, under approval number K181472.

What company makes AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is manufactured by Advanced Sterilization Products (Asp).

What is the FDA product code for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

The FDA product code for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is FEB.

Related PubMed Literature

PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Advanced Sterilization Products (Asp)

K152189EVOTECH ECR K170039STERRAD VELOCITY Biological Indictator and Reader K182404STERRAD VELOCITY Biological Indicator K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

Related Devices (Code: FEB)

K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. K152189EVOTECH ECRAdvanced Sterilization Products (Asp) K172677Advantage Plus Pass-ThruMedivators, Inc. K162120Scope-Assist Flushing SinkCustom Ultrasonics, Inc. K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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