DEN220065 is an FDA 510(k) submission for the Pill Sense System. This device is classified as a Blood Detection Capsule (Class II - Special Controls, product code QUD).
Submitted by Enterasense , Ltd. (Galway, IE). The FDA issued a Not Cleared (DENG) decision on February 24, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1390. Ingestible Gastrointestinal Blood Detection Capsule Device Is A Prescription Device That Uses Spectrophotometry (light Absorption Technology) To Detect The Presence Or Absence Of Blood In The Gastrointestinal Tract..
| 510(k) Number | DEN220065 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 29, 2022 |
| Decision Date | February 24, 2023 |
| Days to Decision | 148 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QUD - Blood Detection Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1390 |
| Definition | Ingestible Gastrointestinal Blood Detection Capsule Device Is A Prescription Device That Uses Spectrophotometry (light Absorption Technology) To Detect The Presence Or Absence Of Blood In The Gastrointestinal Tract. |