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FDA 510(k)

DragonFly Surgical Drill System

K-Number: K161376 · 2016-08-25

ApplicantGrace Medical, Inc.
Decision Date2016-08-25
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DragonFly Surgical Drill System is a medical device manufactured by Grace Medical, Inc.. It received FDA 510(k) clearance on 2016-08-25 under approval number K161376. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DragonFly Surgical Drill System?

DragonFly Surgical Drill System is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by Grace Medical, Inc.. The 510(k) number is K161376.

When was DragonFly Surgical Drill System approved by the FDA?

DragonFly Surgical Drill System received FDA 510(k) clearance on 2016-08-25, under approval number K161376.

What company makes DragonFly Surgical Drill System?

DragonFly Surgical Drill System is manufactured by Grace Medical, Inc..

What is the FDA product code for DragonFly Surgical Drill System?

The FDA product code for DragonFly Surgical Drill System is ERL.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Grace Medical, Inc.

K232059Tympanostomy Tubes

Related Devices (Code: ERL)

K161101PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC K152744DIEGO ELITE DRILLGyrus Acmi, Inc. K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill HandpiecesKarl Storz Endoscopy America, Inc. K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Corporation K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC K180063OCM-G1 AttachmentThe Anspach Effort, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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