510(k) DEN220065
DEN220065 is an FDA 510(k) premarket notification submitted by Enterasense , Ltd. for the device "Pill Sense System". The FDA issued a decision of De Novo Granted on February 24, 2023. The device falls under product code QUD (Blood Detection Capsule), a Class II device regulated under 21 CFR 876.1390.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 24, 2023
- Date Received
- September 29, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood Detection Capsule
- Device Class
- Class II
- Regulation Number
- 876.1390
- Review Panel
- GU
- Submission Type
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.