Definition: Used To Evaluate GI Motility Disorders And Indicated For Use In Evaluating Patients With Suspected Motility Disorders.
| Device Type ID | 2058 |
| Device Name | Gastrointestinal Motility System, Capsule |
| Physical State | Small Ingestible Capsule Transmits Motility Data To A Wireless Receiver Worn By The Subject. Data From The Receiver Is Dowloaded Into A Personal Computer (PC) And Analyzed With Custom Software. |
| Technical Method | Ingestible Telemetric Capsule That Transmits GI Motility Data To A Wireless Receiver Worn By The Patient. |
| Target Area | Device Is Swallowed, And Passes Through The GI Tract |
| Regulation Description | Gastrointestinal Motility Monitoring System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NYV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2058 |
| Device | Gastrointestinal Motility System, Capsule |
| Product Code | NYV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Motility Monitoring System. |
| CFR Regulation Number | 876.1725 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Entrapment Of Device | 2 |
Patient-Device Incompatibility | 1 |
| Total Device Problems | 7 |