FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
K Number: K123864
·
Decision Aug 12, 2013
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
46
Applicant Total
30
Review Days
238
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Basic Information
- Device Name
- GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
- K Number
- K123864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Given Imaging , Ltd.
- Date Received
- December 17, 2012
- Decision Date
- August 12, 2013
- 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 | ||
|---|---|---|---|
| K180171 | PillCam Patency System | Mar 8, 2018 | Substantially Equivalent |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Sep 1, 2017 | Substantially Equivalent |
| K170839 | RAPID Web | May 26, 2017 | Substantially Equivalent |
| 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 |
| 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 |