Cleared Traditional

K984035 - XK-95 HIGH SPEED MOTOR DRILL SYSTEM
(FDA 510(k) Clearance)

K984035 · Komet Medical · Neurology
Jun 1999
Decision
203d
Days
Class 2
Risk

K984035 is an FDA 510(k) clearance for the XK-95 HIGH SPEED MOTOR DRILL SYSTEM, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Komet Medical (Atlanta, US). The FDA issued a Cleared decision on June 3, 1999, 203 days after receiving the submission on November 12, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K984035 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1998
Decision Date June 03, 1999
Days to Decision 203 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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