Cleared Traditional

K021266 - ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018

K021266 is an FDA 510(k) clearance for ENDO WINDOW HIGH FREQUENCY ELECTROCAUTE..., manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K021266 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
158d
Days
Class 2
Risk

K021266 is an FDA 510(k) clearance for the ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 27, 2002 after a review of 158 days - an extended review cycle.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K021266

510(k) Number K021266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2002
Decision Date September 27, 2002
Days to Decision 158 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 131d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

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 169
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K021266.
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PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
K011787 · Vidamed, Inc. · Jul 2001
K021266 · ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
Download PDF FDA Summary Ethicon Endo-Surgery,…