510(k) clearance
OtoCompanion (Version 1.0)
- 510(k) number
- K261725
- Applicant
- Ironsides Medical, Inc.
- Decision date
- Sep 21, 2026
- Date received
- May 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SHL
- Device type
- Ear, Nose, And Throat Image Analyzer
- Device class
- Class II
- Regulation
- 21 CFR 874.4775
- Advisory committee
- Ear, Nose, Throat
- Statement or summary
- Summary
- Third party
- N
- Location
- Cambridge, MA, US