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FDA 510(k)

FIREFLY® Midline Navigation Guide

K-Number: K181883 · 2018-10-03

ApplicantMighty Oak Medical, Inc.
Decision Date2018-10-03
Product CodePQC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIREFLY® Midline Navigation Guide is a medical device manufactured by Mighty Oak Medical, Inc.. It received FDA 510(k) clearance on 2018-10-03 under approval number K181883. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIREFLY® Midline Navigation Guide?

FIREFLY® Midline Navigation Guide is a medical device that received FDA 510(k) clearance on 2018-10-03. It is manufactured by Mighty Oak Medical, Inc.. The 510(k) number is K181883.

When was FIREFLY® Midline Navigation Guide approved by the FDA?

FIREFLY® Midline Navigation Guide received FDA 510(k) clearance on 2018-10-03, under approval number K181883.

What company makes FIREFLY® Midline Navigation Guide?

FIREFLY® Midline Navigation Guide is manufactured by Mighty Oak Medical, Inc..

What is the FDA product code for FIREFLY® Midline Navigation Guide?

The FDA product code for FIREFLY® Midline Navigation Guide is PQC.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING

Other Devices by Mighty Oak Medical, Inc.

K162419FIREFLY® Pedicle Screw Navigation Guide K181399FIREFLY® Pedicle Screw Navigation Guide K220132FIREFLY® Cervical Navigation Guide

Related Devices (Code: PQC)

K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A. K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A. K231483MySpine Unilateral GuidesMedacta International S.A.

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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