SFG — Camera, Surgical, Measurement Class I
FDA product code SFG covers "Camera, Surgical, Measurement", a Class I medical device regulated under 21 CFR 878.4160. 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
- SFG
- Device Class
- Class I
- Regulation Number
- 878.4160
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
An adjunctive tool to measure and record a body parts physical data, such as diameter, surface area, volume, and perimeter/circumference. The device does not provide a diagnosis or therapy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251255 | lymphatech | LymphaTech Mobile 3D Measuring Tool | July 22, 2025 |