XENX— 510(k) K113692

Substantially Equivalent

Xenolith Medical

FDA 510(k) clearance K113692 for XENX, Substantially Equivalent on 2012-08-09. Applicant: Xenolith Medical.

Clearance details

Applicant: Xenolith Medical
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2011-12-15
Decision date: 2012-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kityat-Gat, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.