510(k) K153466
K153466 is an FDA 510(k) premarket notification submitted by Given Imaging , Ltd. for the device "PillCam COLON 2 Capsule Endoscopy System". The FDA issued a decision of Substantially Equivalent on January 14, 2016. 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
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2016
- Date Received
- December 1, 2015
- Clearance Type
- Traditional
- 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