Cleared Traditional

P300 Attachment

K202120 · Nakanishi, Inc. · Neurology
Oct 2021
Decision
449d
Days
Class 2
Risk

About This 510(k) Submission

K202120 is an FDA 510(k) clearance for the P300 Attachment, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on October 22, 2021, 449 days after receiving the submission on July 30, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K202120 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2020
Decision Date October 22, 2021
Days to Decision 449 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

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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