FDA Product Code
FDA Product Code PIE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172128 | EsoFLIP® ES-310 Balloon Catheter | Crospon, Ltd. | 2017-11-22 | Traditional | PDF ↗ |
| K142000 | ESOFLIP ES | Crospon, Ltd. | 2014-09-25 | Traditional | PDF ↗ |
Product code PIE · Class II · Gastroenterology, Urology. Data: openFDA.