K250940 is an FDA 510(k) clearance for the Atmo Gas Capsule System. This device is classified as a Gastrointestinal Motility System, Capsule (Class II - Special Controls, product code NYV).
Submitted by Atmo Biosciences, Ltd. (Box Hill, AU). The FDA issued a Cleared decision on June 26, 2025, 90 days after receiving the submission on March 28, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725. Used To Evaluate Gi Motility Disorders And Indicated For Use In Evaluating Patients With Suspected Motility Disorders..
| 510(k) Number | K250940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2025 |
| Decision Date | June 26, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NYV - Gastrointestinal Motility System, Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |
| Definition | Used To Evaluate Gi Motility Disorders And Indicated For Use In Evaluating Patients With Suspected Motility Disorders. |