EPISIL— 510(k) K101769

Substantially Equivalent

Camurus AB

FDA 510(k) clearance K101769 for EPISIL, Substantially Equivalent on 2011-09-13. Applicant: Camurus AB.

Clearance details

Applicant: Camurus AB
Product code: Code OLR
Advisory panel: Unknown
Date received: 2010-06-24
Decision date: 2011-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.