QUD — Blood Detection Capsule Class II
FDA product code QUD covers "Blood Detection Capsule", a Class II medical device regulated under 21 CFR 876.1390. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QUD
- Device Class
- Class II
- Regulation Number
- 876.1390
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220065 | enterasense | Pill Sense System | February 24, 2023 |