FDA Product Code
FDA Product Code PGD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1330
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153466 | PillCam COLON 2 Capsule Endoscopy System | Given Imaging , Ltd. | 2016-01-14 | Traditional | PDF ↗ |
| DEN120023 | GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM | Given Imaging , Ltd. | 2014-01-29 | Direct | — |
Product code PGD · Class II · Gastroenterology, Urology. Data: openFDA.