FDA 510(k)

CLEAR™ Aspiration System

Número K: K253404 · 2026-06-24

Data da decisão2026-06-24

Código do produto

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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