CLEAR™ Aspiration System
K-Number: K253404 · 2026-06-24
ApplicantInsera Therapeutics, Inc.
Decision Date2026-06-24
Product Code
DecisionSubstantially Equivalent
Device Summary
CLEAR™ Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Insera Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K253404. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CLEAR™ Aspiration System?
CLEAR™ Aspiration System is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Insera Therapeutics, Inc.. The 510(k) number is K253404.
When did CLEAR™ Aspiration System receive FDA 510(k) clearance?
CLEAR™ Aspiration System received FDA 510(k) clearance on 2026-06-24, under 510(k) number K253404.
Who is the listed applicant for CLEAR™ Aspiration System?
The FDA 510(k) record lists Insera Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.