Acu-sInQ Complete Endoscope Cleaning Aid System— 510(k) K181865

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K181865 for Acu-sInQ Complete Endoscope Cleaning Aid System, Substantially Equivalent on 2018-12-14. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2018-07-12
Decision date: 2018-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, 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.