Cleared Traditional

K161376 - DragonFly Surgical Drill System

K161376 is an FDA 510(k) clearance for DragonFly Surgical Drill System, manufactured by Grace Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K161376 · Grace Medical, Inc. · Ear, Nose, Throat device
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Aug 2016
Decision
99d
Days
Class 2
Risk

K161376 is an FDA 510(k) clearance for the DragonFly Surgical Drill System. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on August 25, 2016 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Grace Medical, Inc. devices

FDA 510(k) Submission Details - K161376

510(k) Number K161376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 90d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ERL Device Classification - Class 2, Special Controls

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Third Party Review Group, LLC
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The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 77
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K161376.
OCM-G1 Attachment
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K152744 · Gyrus Acmi, Inc. · Jun 2016
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
K150969 · KARL STORZ Endoscopy-America, Inc. · Jan 2016

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.