Cleared Traditional

IntelliSense Drill

K143191 · Mcginley Innovations · Orthopedic

Feb 2015

Decision

106d

Days

Class 1

Risk

About This 510(k) Submission

K143191 is an FDA 510(k) clearance for the IntelliSense Drill, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Mcginley Innovations (Casper, US). The FDA issued a Cleared decision on February 20, 2015, 106 days after receiving the submission on November 6, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K143191 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2014
Decision Date	February 20, 2015
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820