OtoCompanion (Version 1.0)— 510(k) K261725
Substantially EquivalentIronsides Medical, Inc.
FDA 510(k) clearance K261725 for OtoCompanion (Version 1.0), Substantially Equivalent on 2026-09-21. Applicant: Ironsides Medical, Inc.. Device class: 2.
Summary
OtoCompanion (Version 1.0) is from Ironsides Medical, Inc., filed under product code SHL (Ear, Nose, And Throat Image Analyzer). The record gives the name and version number and nothing about what the device does.
Class II, 21 CFR 874.4775. Ear, Nose, Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Ironsides Medical filed from Cambridge, Massachusetts. The decision came 118 calendar days after FDA received it (May 26 to September 21, 2026).
Clearance details
- Applicant
- Ironsides Medical, Inc.
- Product code
- Product code SHL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4775
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code SHL
view allData sourced from openFDA. This site is unofficial and independent of the FDA.