DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE— 510(k) K034004
Substantially EquivalentGyrus 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. Device class: 2.
Clearance details
- Applicant
- Gyrus Ent LLC
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
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Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
Source: openFDA MAUDE database, through . 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.