GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
FDA 510(k) clearance DEN120023 · decided 2014-01-29
Clearance details
- K-number
- DEN120023
- Device name
- GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
- Applicant
- Given Imaging , Ltd.
- Decision
- Unknown
- Date received
- 2012-11-29
- Decision date
- 2014-01-29
- Days to decision
- 426 days
- Clearance type
- Direct
- Product code
- PGD
- Device class
- 2
- Regulation number
- 876.1330
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Yoqneam, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PillCam COLON 2 Capsule Endoscopy System (K153466) | Given Imaging , Ltd. | 2016-01-14 |
Recalls involving this device
No recalls on record reference this clearance.