510(k) K180171
- Device
- PillCam Patency System
- Applicant
- Given Imaging Ltd.
- 510(k) number
- K180171
- Product code
- NSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-08
- Date received
- 2018-01-22
- Regulation
- 876.1300
- Classification name
- System, Imaging, Esophageal, Wireless, Capsule
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hilla Debby
- Address
- 2 Hacarmet St. New Industrial Park Pob 258 Yoqneam IL 20692 20692
FDA Registration Numbers#
- 9710107
- 3018094310
Source Documents#
Other 510(k) Records For Product Code NSI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM | Given Imaging , Ltd. | 2009-09-28 |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | Given Imaging , Ltd. | 2007-06-11 |
| K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-05-24 |
| K052184 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2005-12-01 |
| K042960 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO | Given Imaging , Ltd. | 2004-11-24 |
| K041149 | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE | Given Imaging , Ltd. | 2004-10-25 |
Legacy Summary#
summary
FDA Review#
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