DragonFly Surgical Drill System— 510(k) K161376
Substantially EquivalentGrace Medical, Inc.
FDA 510(k) clearance K161376 for DragonFly Surgical Drill System, Substantially Equivalent on 2016-08-25. Applicant: Grace Medical, Inc..
Clearance details
- Applicant
- Grace Medical, Inc.
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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.