PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
FDA 510(k) clearance K101200 · decided 2010-09-30
Clearance details
- K-number
- K101200
- Device name
- PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
- Applicant
- Given Imaging , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-29
- Decision date
- 2010-09-30
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- NEZ
- Device class
- 2
- Regulation number
- 876.1300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Yokneam (P.O.Box 258), IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Given Imaging
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopi recall (Z-1748-2011) | Given Imaging Ltd. | 2011-03-23 |