NYV
5 FDA 510(k) clearances · Product code
90 daysmedian time to decision
210 days90th percentile
5clearances measured
FDA profile
- Official device name
- Gastrointestinal Motility System, Capsule
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Atmo Gas Capsule System (K253569) | Atmo Biosciences, Ltd. | 2026-05-22 |
| Atmo Gas Capsule System (K250940) | Atmo Biosciences, Ltd. | 2025-06-26 |
| MotiliCap GI Monitoring System (K250493) | Anx Robotica Corporation | 2025-05-21 |
| SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 (K092342) | The Smartpill Corporation | 2009-10-30 |
| SMARTPILL GI MONITORING SYSTEM (K053547) | The Smartpill Corporation | 2006-07-18 |
Track NYV automatically
Every clearance here is in the API, with alerts when new ones post.