FEH — Electrode, Flexible Suction Coagulator Class II
FDA product code FEH covers "Electrode, Flexible Suction Coagulator", a Class II medical device regulated under 21 CFR 876.4300. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FEH
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K130489 | optim | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | April 19, 2013 |
| K122593 | optim | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI- | September 13, 2012 |
| K803214 | american cystocope makers | ACMI BIPOLAR HEMOSTATIC ELECTRODE | January 15, 1981 |