Product code SFG
- Device name
- Camera, Surgical, Measurement
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4160
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An adjunctive tool to measure and record a body partÂ’s physical data, such as diameter, surface area, volume, and perimeter/circumference. The device does not provide a diagnosis or therapy.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K251255 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | 2025-07-22 |