FDA Product Code
FDA Product Code PID — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182895 | Wilson-Cook Achalasia Balloon | Wilson-Cook Medical, Inc. | 2019-01-25 | Traditional | PDF ↗ |
| K132337 | ESOFLIP BALLOON DILATION CATHETER | Crospon, Ltd. | 2013-10-07 | Traditional | PDF ↗ |
| K050232 | RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR | Boston Scientific Corp | 2005-03-11 | Special | PDF ↗ |
Product code PID · Class II · Gastroenterology, Urology. Data: openFDA.