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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 the device name listed in this FDA 510(k) record. The listed applicant is Grace Medical, Inc.. It received FDA 510(k) clearance on 2016-08-25 under 510(k) 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. The listed applicant is Grace Medical, Inc.. The 510(k) number is K161376.

When did DragonFly Surgical Drill System receive FDA 510(k) clearance?

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

Who is the listed applicant for DragonFly Surgical Drill System?

The FDA 510(k) record lists Grace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Grace Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232059Tympanostomy Tubes

Related Devices (Code: ERL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

Official Source

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

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