510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250268Substantially Equivalent

HyperSnap Surgical System (HSS)

Hypervision Surgical, London, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250268 is the FDA 510(k) clearance record for HyperSnap Surgical System (HSS), a class II device, cleared for Hypervision Surgical on under FDA product code SFE (Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation). FDA's definition for product code SFE reads: "To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor". FDA records list one 510(k) clearance for Hypervision Surgical. As of , FDA records show no recalls naming K250268.

Clearance record

Decision date
Received
(145 days to decision)
Product code
SFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hypervision Surgical London Institute For Healthcare Engineering, London, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SFE

Trailing 12 months
1 clearance under product code SFE in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SFE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260