Atmo Gas Capsule System— 510(k) K253569

Substantially Equivalent

Atmo Biosciences, Ltd.

FDA 510(k) clearance K253569 for Atmo Gas Capsule System, Substantially Equivalent on 2026-05-22. Applicant: Atmo Biosciences, Ltd.. Device class: 2.

Clearance details

Applicant: Atmo Biosciences, Ltd.
Product code: Code NYV
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-17
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Box Hill, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.