FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
K Number: DEN120023
·
Decision Jan 29, 2014
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
30
Review Days
426
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Basic Information
- Device Name
- GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
- K Number
- DEN120023
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.1330
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Given Imaging , Ltd.
- Date Received
- November 29, 2012
- Decision Date
- January 29, 2014
- Product Code
- PGD
- 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 |
|---|---|---|---|
| PGD | Colon Capsule Imaging System | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PGD), ordered by most recent decision date.
View allOther 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 |
| 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 |