Cleared Traditional

K262235 - ApexCut ™ Blade with Automated EM Tracking (187BL4012EM)

Also marketed or referenced as:
ApexCut ™ Blade with Automated EM Tracking (187BL4040EM) ApexCut ™ Blade with Automated EM Tracking (187BL4060EM) ApexCut ™ Blade with Automated EM Tracking (187BL2975EM) ApexCut ™ Blade with Automated EM Tracking (187BL3590EM) ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)

K262235 is an FDA 510(k) clearance for ApexCut Blade with Automated EM Trackin..., manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K262235 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
65d
Days
Class 2
Risk

K262235 is an FDA 510(k) clearance for the ApexCut ™ Blade with Automated EM Tracking (187BL4012EM). Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 4, 2026 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.4560 - the FDA ear, nose and throat 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K262235

510(k) Number K262235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2026
Decision Date September 04, 2026
Days to Decision 65 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 90d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGW Device Classification - Class 2, Special Controls

Product Code PGW Ear, Nose, And Throat Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Intended As An Aid For Precisely Locating A Surgical Instrument Within Anatomical Structures In Either Open Or Percutaneous Procedures For Any Medical Condition In Which A Reference To A Rigid Anatomical Structure In The Field Of Ent Surgery Can Be Identified Relative To A Ct- Or Mr-based Model Or Digitized Landmarks Of The Anatomy.
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - PGW Ear, Nose, And Throat Stereotaxic Instrument

All 37
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K262235.
Cube 4D Navigation System, VirtuEye Pro
K261540 · Fiagon GmbH · Jun 2026
Stealth AXiS™ ENT clinical application
K253395 · Medtronic Navigation, Inc. · Mar 2026
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K243053 · Claronav · Jun 2025
TruDi® Navigation System V3 (FG-2000-00)
K231862 · Acclarent, Inc. · Jul 2023
ENT EM
K223734 · Brainlab AG · Apr 2023
TruDi Shaver Blade
K221037 · Acclarent, Inc. · Jul 2022