510(k) DEN120023
- Device
- GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
- Applicant
- Given Imaging , Ltd.
- 510(k) number
- DEN120023
- Product code
- PGD
- Decision
- Unknown (DENG)
- Decision date
- 2014-01-29
- Date received
- 2012-11-29
- Regulation
- 876.1330
- Classification name
- Colon Capsule Imaging System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tim Thomas
- Address
- Hermon Bldg., New Industrial Park, P.O. Box 258 Yoqneam IL 20692 20692
FDA Registration Numbers#
- 9710107
- 3018094310
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PGD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153466 | PillCam COLON 2 Capsule Endoscopy System | Given Imaging , Ltd. | 2016-01-14 |