DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE— 510(k) K034004

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K034004 for DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE, Substantially Equivalent on 2004-03-03. Applicant: Gyrus Ent LLC.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2003-12-24
Decision date: 2004-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.