DeviceClearance

DragonFly Surgical Drill System— 510(k) K161376

Substantially Equivalent

Grace Medical, Inc.

FDA 510(k) clearance K161376 for DragonFly Surgical Drill System, Substantially Equivalent on 2016-08-25. Applicant: Grace Medical, Inc.. Device class: 2.

Clearance details

Applicant
Grace Medical, Inc.
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
Memphis, TN, US
Download summary PDFView on FDA.gov ↗

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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.