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Panels › Gastroenterology, Urology › Product code SFE · Class 2

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

Regulation 876.1500

1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in SFE

Company510(k)sRecalls
Covidien, LLC10
Hypervision Surgical10
Decided510(k)Device and applicantCode
Jun 4, 2026K253984Instrument Exit Point on Touch Surgery™ Aide
Covidien, LLC
SFE
Jun 24, 2025K250268HyperSnap Surgical System (HSS)
Hypervision Surgical, GB
SFE

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