EYC — Catheter, Upper Urinary Tract Class II
FDA product code EYC covers "Catheter, Upper Urinary Tract", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EYC
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200757 | deroyal industries | Foley Catheter with Temperature Sensor | October 15, 2020 |
| K061918 | ge healthcare | FOLEY CATHETERS WITH TEMPERATURE PROBE | August 18, 2006 |
| K041416 | deroyal | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | July 2, 2004 |
| K925790 | deroyal industries | EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S | May 17, 1993 |
| K890310 | kosan far east ent. | STERILE FOLEY CATHETER | November 30, 1989 |