System 83 Plus Washer/Disinfector— 510(k) K173590

Substantially Equivalent

Custom Ultrasonics, Inc.

FDA 510(k) clearance K173590 for System 83 Plus Washer/Disinfector, Substantially Equivalent on 2020-03-30. Applicant: Custom Ultrasonics, Inc..

Clearance details

Applicant: Custom Ultrasonics, Inc.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2017-11-21
Decision date: 2020-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ivyland, PA, 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.