FDA 510(k) clearance · back to tracker

Atmo Gas Capsule System

Atmo Biosciences, Ltd. cleared K253569 on 2026-05-22, decision: substantially equivalent

K-number

K253569

Sponsor

Atmo Biosciences, Ltd.

Device

Atmo Gas Capsule System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-22

Product code

NYV

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1725

Official FDA record

Open K253569on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.