NYV
- Product code
- NYV
- Device name
- Gastrointestinal Motility System, Capsule
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1725
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 5 (all years; only the last 3 years are listed here)
FDA classification definition
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253569 | 2026-05-22 | Atmo Biosciences, Ltd. | Atmo Gas Capsule System | |
| K250940 | 2025-06-26 | Atmo Biosciences, Ltd. | Atmo Gas Capsule System | |
| K250493 | 2025-05-21 | Anx Robotica Corporation | MotiliCap GI Monitoring System |
Official FDA classification page: NYV
Classification and pathway per current FDA publications. Data from openFDA (CC0).