NYV · Gastrointestinal Motility System, Capsule
Gastroenterology, Urology · 21 CFR 876.1725 · Class 2
Overview
| Product Code | NYV |
|---|---|
| Device Name | Gastrointestinal Motility System, Capsule |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250940 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | Jun 26, 2025 | SESE |
| K250493 | MotiliCap GI Monitoring System | Anx Robotica Corporation | May 21, 2025 | SESE |
| K092342 | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 | The Smartpill Corporation | Oct 30, 2009 | SESE |
| K053547 | SMARTPILL GI MONITORING SYSTEM | The Smartpill Corporation | Jul 18, 2006 | SESE |
Top Applicants
- The Smartpill Corporation — 2 clearances
- Anx Robotica Corporation — 1 clearance
- Atmo Biosciences, Ltd. — 1 clearance
