Cleared Traditional

K253602 - Precision S 4K Sinuscope

K253602 is an FDA 510(k) clearance for Precision S 4K Sinuscope, manufactured by Stryker Endoscopy. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K253602 · Stryker Endoscopy · Neurology device
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Jun 2026
Decision
198d
Days
Class 2
Risk

K253602 is an FDA 510(k) clearance for the Precision S 4K Sinuscope. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on June 4, 2026 after a review of 198 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Endoscopy devices

FDA 510(k) Submission Details - K253602

510(k) Number K253602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2025
Decision Date June 04, 2026
Days to Decision 198 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 148d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWG Device Classification - Class 2, Special Controls

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Neurology devices follow this clearance model.

Regulatory Peers - GWG Endoscope, Neurological

All 84
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K253602.
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K250752 · Integra LifeSciences Corporation · Apr 2025
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K233391 · VPIX Medical, Inc. · Aug 2024
Digital ClarusScope System, Digital NeuroPEN System
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K232618 · Rebound Therapeutics Corporation · Oct 2023