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FDA 510(k)

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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