SYSTEM 83 PLUS— 510(k) K122172

Substantially Equivalent

Custom Ultrasonics

FDA 510(k) clearance K122172 for SYSTEM 83 PLUS, Substantially Equivalent on 2013-01-25. Applicant: Custom Ultrasonics.

Clearance details

Applicant: Custom Ultrasonics
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2012-07-23
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Special
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.