GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
FDA 510(k) clearance K071153 · decided 2007-06-11
Clearance details
- K-number
- K071153
- Device name
- GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
- Applicant
- Given Imaging , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-25
- Decision date
- 2007-06-11
- Days to decision
- 47 days
- Clearance type
- Special
- Product code
- NSI
- Device class
- 2
- Regulation number
- 876.1300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Calgary, Alberta, CA
- 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 Patency System (K180171) | Given Imaging , Ltd. | 2018-03-08 |
| GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM (K090557) | Given Imaging , Ltd. | 2009-09-28 |
| MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K060805) | Given Imaging , Ltd. | 2006-05-24 |
| GIVEN DIAGNOSTIC SYSTEM (K052184) | Given Imaging , Ltd. | 2005-12-01 |
| GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO (K042960) | Given Imaging , Ltd. | 2004-11-24 |
| GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE (K041149) | Given Imaging , Ltd. | 2004-10-25 |
Recalls involving this device
No recalls on record reference this clearance.