GXE — Leukotome Class I
FDA product code GXE covers "Leukotome", a Class I medical device regulated under 21 CFR 882.4600. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GXE
- Device Class
- Class I
- Regulation Number
- 882.4600
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K915741 | dantec medical | DISPOSABLE MONOPLAR MEDDLE ELECTRODES | December 8, 1992 |