SFG · Camera, Surgical, Measurement
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | SFG |
|---|---|
| Device Name | Camera, Surgical, Measurement |
| Regulation | 21 CFR 878.4160 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical camera and accessories is a device intended to be used to record operative procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251255 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | Jul 22, 2025 | SESE |
Top Applicants
- Lymphatech, Inc. — 1 clearance
