ApexCut Blade with Automated EM Tracking (187BL4012EM);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)
FDA 510(k) K262235 · Medtronic Xomed, Inc.
Submission
- Device name
- ApexCut Blade with Automated EM Tracking (187BL4012EM);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)
- Applicant
- Medtronic Xomed, Inc.
Jacksonville, FL, US - Received
- July 1, 2026
- Decision date
- September 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
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.
Other 510(k)s with product code PGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | Fiagon GmbH | 06/02/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | Medtronic Navigation, Inc. | 03/16/2026SE |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC)PGW · Traditional | Claronav | 06/20/2025SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | Acclarent, Inc. | 07/21/2023SE |
| K223734 | ENT EmPGW · Traditional | Brainlab AG | 04/27/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | Acclarent, Inc. | 07/20/2022SE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…PGW · Traditional | Stryker Corporation | 07/12/2022SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | Fiagon GmbH | 07/19/2021SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | Stryker Corporation | 10/09/2020SE |
| K201174 | TruDi CurettePGW · Traditional | Acclarent, Inc. | 08/12/2020SE |
More from Acclarent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube…ETN · Traditional | 02/10/2026SE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | 10/26/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | 08/30/2023SE |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM…ETN · Traditional | 03/21/2022SE |
| K210841 | NuVent Eustachian Tube Dilation BalloonPNZ · Traditional | 08/16/2021SE |
| K202623 | Novapak Nasal Sinus Packing and StentLYA · Traditional | 12/08/2020SE |
| K200759 | NIM Vital, Nerve Integrity MonitorGWF · Traditional | 10/28/2020SE |
| K173855 | Sharpsite AC Rigid EndsocopeEOB · Traditional | 04/20/2018SE |
| K152121 | NuVent EM Sinus Dilation SystemLRC · Traditional | 12/01/2015SE |
| K151758 | ALAR Nasal Valve StentGAT · Traditional | 10/29/2015SE |
Questions and answers
When was ApexCut Blade with Automated EM Tracking (187BL4012EM);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) cleared by the FDA?
ApexCut Blade with Automated EM Tracking (187BL4012EM);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) received a 510(k) decision of Substantially Equivalent on September 4, 2026, 65 days after the submission was received.
What is the product code of K262235?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.