Cleared Traditional

K250268 - HyperSnap Surgical System (HSS) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250268 · Hypervision Surgical · General & Plastic Surgery device
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Jun 2025
Decision
145d
Days
Class 2
Risk

K250268 is an FDA 510(k) clearance for the HyperSnap Surgical System (HSS). Classified as Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation (product code SFE), Class II - Special Controls.

Submitted by Hypervision Surgical (London, GB). The FDA issued a Cleared decision on June 24, 2025 after a review of 145 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hypervision Surgical devices

Submission Details

510(k) Number K250268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2025
Decision Date June 24, 2025
Days to Decision 145 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 114d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope With Real Time Augmentation Of Video Images Via Software To A Monitor.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.