Atmo Gas Capsule System— 510(k) K253569
Substantially EquivalentAtmo 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.
Summary
Atmo Biosciences filed the Atmo Gas Capsule System under NYV, capsule gastrointestinal motility systems.
Class II, 21 CFR 876.1725. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Atmo filed from Box Hill, Australia. Review took 186 calendar days (November 17, 2025 to May 22, 2026).
Clearance details
- Applicant
- Atmo Biosciences, Ltd.
- Product code
- Product code NYV
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Box Hill, AU
Recent devices under product code NYV
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