FAA — Replacer, Urethral Class III
FDA product code FAA covers "Replacer, Urethral", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FAA
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K833690 | american edwards laboratories | COAXIAL BALLOON URETHRAL DILATOR | November 29, 1983 |