FDA product code SFG: Camera, Surgical, Measurement
SFG is the FDA product code for camera, surgical, measurement. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under SFG, 1 in the last five years. The average 510(k) review took 90 days (median 90); 90 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Surgical, Measurement |
| Device class | Class I |
| Regulation | 21 CFR 878.4160 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for SFG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every SFG clearance
Top SFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lymphatech, Inc. | 1 | 2025-07-22 |
Most recent SFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251255 | Lymphatech, Inc. | LymphaTech Mobile 3D Measuring Tool | 2025-07-22 | 90 |
Recalls for SFG devices
openFDA lists no recalls for product code SFG.
Frequently asked questions
What is FDA product code SFG?
SFG is the FDA product code for camera, surgical, measurement. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel.
What device class is SFG?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code SFG?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most SFG clearances?
Lymphatech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFG
- Run a recall and safety report across every SFG manufacturer
- Watch product code SFG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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