Cleared Traditional

K161704 - Phasor Drill

K161704 is an FDA 510(k) clearance for Phasor Drill, manufactured by Biotex, Inc.. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K161704 · Biotex, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
164d
Days
Class 2
Risk

K161704 is an FDA 510(k) clearance for the Phasor Drill. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Biotex, Inc. (Houston, US). The FDA issued a Cleared decision on December 1, 2016 after a review of 164 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotex, Inc. devices

FDA 510(k) Submission Details - K161704

510(k) Number K161704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2016
Decision Date December 01, 2016
Days to Decision 164 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 148d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 42
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K161704.
ELAN 4 Tools
K182527 · Aesculap, Inc. · Jan 2019
ELAN 4 Electro Motor System Tools
K172709 · Aesculap, Inc. · Oct 2018
POWEREASE System
K182436 · Medtronic Sofamor Danek USA, Inc. · Oct 2018
Stryker Footed Attachments and Cutting Accessories
K143399 · Stryker Corp. · May 2015
Stryker MIS Attachments and Cutting Accessories
K143540 · Stryker Corporation · May 2015
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K143320 · Stryker Corp. · Apr 2015