PillCam COLON 2 Capsule Endoscopy System
FDA 510(k) clearance K153466 · decided 2016-01-14
Clearance details
- K-number
- K153466
- Device name
- PillCam COLON 2 Capsule Endoscopy System
- Applicant
- Given Imaging , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-01
- Decision date
- 2016-01-14
- Days to decision
- 44 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (DEN120023) | Given Imaging , Ltd. | 2014-01-29 |
Recalls involving this device
No recalls on record reference this clearance.