510(k) clearance
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)
- 510(k) number
- K262235
- Applicant
- Medtronic Xomed, Inc.
- Decision date
- Sep 4, 2026
- Date received
- Jul 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PGW
- Device type
- Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II
- Regulation
- 21 CFR 882.4560
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Jacksonville, FL, US