Cleared Traditional

DragonFly Surgical Drill System

K161376 · Grace Medical, Inc. · Ear, Nose, Throat

Aug 2016

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K161376 is an FDA 510(k) clearance for the DragonFly Surgical Drill System, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on August 25, 2016, 99 days after receiving the submission on May 18, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K161376 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2016
Decision Date	August 25, 2016
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4250