ENDO SMARTCAP— 510(k) K093665

Substantially Equivalent

Byrne Medical, Inc.

FDA 510(k) clearance K093665 for ENDO SMARTCAP, Substantially Equivalent on 2009-12-15. Applicant: Byrne Medical, Inc..

Clearance details

Applicant: Byrne Medical, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2009-11-25
Decision date: 2009-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.