FDA product code SFE: Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
SFE is the FDA product code for endoscopic video imaging system / software component for real time video augmentation. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under SFE, 2 in the last five years, from 2 different applicants. The average 510(k) review took 160 days (median 160); 160 days on average over the last three years.
Definition
To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for SFE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 145 |
| 2026 | 1 | 174 |
Compare with all 510(k) review times · Search every SFE clearance
Top SFE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Covidien, LLC | 1 | 2026-06-04 |
| Hypervision Surgical | 1 | 2025-06-24 |
Most recent SFE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253984 | Covidien, LLC | Instrument Exit Point on Touch Surgery Aide | 2026-06-04 | 174 |
| K250268 | Hypervision Surgical | HyperSnap Surgical System (HSS) | 2025-06-24 | 145 |
Recalls for SFE devices
openFDA lists no recalls for product code SFE.
Frequently asked questions
What is FDA product code SFE?
SFE is the FDA product code for endoscopic video imaging system / software component for real time video augmentation. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is SFE?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFE?
Across 2 cleared submissions the average was 160 days from receipt to decision (median 160).
Which companies have the most SFE clearances?
Covidien, LLC (1); Hypervision Surgical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFE
- Run a recall and safety report across every SFE manufacturer
- Watch product code SFE 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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