510(k) DEN120023
DEN120023 is an FDA 510(k) premarket notification submitted by Given Imaging , Ltd. for the device "GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM". The FDA issued a decision of De Novo Granted on January 29, 2014. The device falls under product code PGD (Colon Capsule Imaging System), a Class II device regulated under 21 CFR 876.1330. Given Imaging , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 29, 2014
- Date Received
- November 29, 2012
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colon Capsule Imaging System
- Device Class
- Class II
- Regulation Number
- 876.1330
- Review Panel
- GU
- Submission Type
visualization of the colon for the detection of polyps