Product code PGD— Gastroenterology, Urology
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
- Classification name
- Colon Capsule Imaging System
- Device class
- Class 2
- Regulation
- 21 CFR 876.1330
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“visualization of the colon for the detection of polyps”
Market context for product code PGD
FDA has cleared devices under product code PGD between 2014 and 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2016
- 2014
Top applicants under product code PGD
Recent clearances under product code PGD
Data sourced from openFDA. This site is unofficial and independent of the FDA.