NYV — Gastrointestinal Motility System, Capsule Class II
Classification Details
- Product Code
- NYV
- Device Class
- Class II
- Regulation Number
- 876.1725
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250940 | atmo biosciences | Atmo Gas Capsule System | June 26, 2025 |
| K250493 | anx robotica corporation | MotiliCap GI Monitoring System | May 21, 2025 |
| K092342 | smartpill corporation | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 | October 30, 2009 |
| K053547 | smartpill corporation | SMARTPILL GI MONITORING SYSTEM | July 18, 2006 |