OtoCompanion (Version 1.0)
K-Number: K261725 · 2026-09-21
ApplicantIronsides Medical, Inc.
Decision Date2026-09-21
Product CodeSHL
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
OtoCompanion (Version 1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ironsides Medical, Inc.. It received FDA 510(k) clearance on 2026-09-21 under 510(k) number K261725. The device is classified under product code SHL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OtoCompanion (Version 1.0)?
OtoCompanion (Version 1.0) is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is Ironsides Medical, Inc.. The 510(k) number is K261725.
When did OtoCompanion (Version 1.0) receive FDA 510(k) clearance?
OtoCompanion (Version 1.0) received FDA 510(k) clearance on 2026-09-21, under 510(k) number K261725.
Who is the listed applicant for OtoCompanion (Version 1.0)?
The FDA 510(k) record lists Ironsides Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OtoCompanion (Version 1.0)?
The FDA product code for OtoCompanion (Version 1.0) is SHL.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.