FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
K Number: K070475
·
Decision May 7, 2007
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
44
Applicant Total
27
Review Days
76
Basic Information
- Device Name
- MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
- K Number
- K070475
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GIVEN IMAGING LTD.
- Date Received
- February 20, 2007
- Decision Date
- May 7, 2007
- Product Code
- NEZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by GIVEN IMAGING LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K151086 | ManoScan System | Apr 28, 2016 | Substantially Equivalent |
| K153466 | PillCam COLON 2 Capsule Endoscopy System | Jan 14, 2016 | Substantially Equivalent |
| K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | Dec 17, 2014 | Substantially Equivalent |
| DEN120023 | GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM | Jan 29, 2014 | Unknown |
| K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | Aug 12, 2013 | Substantially Equivalent |
| K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES | May 13, 2011 | Substantially Equivalent |
| K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES | Mar 7, 2011 | Substantially Equivalent |
| K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT | Jan 14, 2011 | Substantially Equivalent |
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | Dec 1, 2010 | Substantially Equivalent |
| K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE | Sep 30, 2010 | Substantially Equivalent |