510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFEClass II

Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

SFE is the FDA product code for Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SFE
Device name
Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
FDA definition
To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SFE

By decision year
2 clearances under product code SFE with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFE by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code SFE
Applicants holding the most 510(k) clearances under product code SFE
ApplicantClearances
Medtronic, Inc.1
Hypervision Surgical1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SFE.