510(k) K253569
K253569 is an FDA 510(k) premarket notification submitted by Atmo Biosciences, Ltd. for the device "Atmo Gas Capsule System". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code NYV (Gastrointestinal Motility System, Capsule), a Class II device regulated under 21 CFR 876.1725. Atmo Biosciences, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2026
- Date Received
- November 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Motility System, Capsule
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.