K053547 is an FDA 510(k) clearance for the SMARTPILL GI MONITORING SYSTEM, a Gastrointestinal Motility System, Capsule (Class II — Special Controls, product code NYV), submitted by The Smartpill Corporation (Buffalo, US). The FDA issued a Cleared decision on July 18, 2006, 210 days after receiving the submission on December 20, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K053547 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2005 |
| Decision Date | July 18, 2006 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NYV — Gastrointestinal Motility System, Capsule |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1725 |
| Definition | Used To Evaluate Gi Motility Disorders And Indicated For Use In Evaluating Patients With Suspected Motility Disorders. |