AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor— 510(k) K181472

Substantially Equivalent

Advanced Sterilization Products (Asp)

FDA 510(k) clearance K181472 for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor, Substantially Equivalent on 2019-04-23. Applicant: Advanced Sterilization Products (Asp).

Clearance details

Applicant: Advanced Sterilization Products (Asp)
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-04
Decision date: 2019-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.