K253569
- 510(k) number
- K253569
- Device name
- Atmo Gas Capsule System
- Applicant
- Atmo Biosciences, Ltd. AU
- Product code
- NYV — Gastrointestinal Motility System, Capsule
- Decision date
- 2026-05-22
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K253569.pdf
Official FDA record: K253569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.