Cleared Traditional

STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM (K033135) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033135 · Stryker Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
314d
Days
Class 2
Risk

K033135 is an FDA 510(k) clearance for the STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on August 9, 2004 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Endoscopy devices

Submission Details

510(k) Number K033135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date August 09, 2004
Days to Decision 314 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 130d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 187
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K033135.
Sphincterotome
K260962 · Taewoong Medical Co., Ltd. · May 2026
Vanquish Water Vapor Ablation Device
K252388 · Francis Medical, Inc. · Nov 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · Olympus Medical Systems Corporation · Nov 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · Olympus Medical Systems Corp. · Oct 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U)
K250351 · Olympus Medical Systems Corporation · Oct 2025
SureTome™ SW Sphincterotome with DomeTip
K251104 · Wilson Cook Medical · Sep 2025