AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION— 510(k) K093672

Substantially Equivalent

Sentinelle Medical, Inc.

FDA 510(k) clearance K093672 for AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION, Substantially Equivalent on 2009-12-11. Applicant: Sentinelle Medical, Inc..

Clearance details

Applicant: Sentinelle Medical, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-11-27
Decision date: 2009-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.