FXF — Speculum, Illuminated Class I
FDA product code FXF covers "Speculum, Illuminated", a Class I medical device regulated under 21 CFR 878.1800. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FXF
- Device Class
- Class I
- Regulation Number
- 878.1800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K801058 | designs for vision | ILLUMINATED SPECULUM | May 28, 1980 |