Cleared Traditional

K021266 - ENDO WINDOW HIGH FREQUENCY ELECTROCAUTE...

K021266 is the FDA 510(k) clearance for ENDO WINDOW HIGH FREQUENCY ELECTROCAUTE... by Ethicon Endo-Surgery, Inc.. It is a Class 2 Gastroenterology & Urology device (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)
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.

View all Ethicon Endo-Surgery, Inc. devices

Submission Details

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
28d slower than avg
Panel avg: 130d · This submission: 158d
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 94
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K021266.
USW NEEDLEKNIFE PAPILLOTOME
K040981 · Wilson-Cook Medical, Inc. · May 2004
WILSON-COOK TRI-TOME SELECT PLUS
K033203 · Wilson-Cook Medical, Inc. · Dec 2003
WILSON-COOK CYSTOTOME
K022595 · Wilson-Cook Medical, Inc. · Oct 2002
AUTOTOME RX MODEL # 4515, 4516
K013153 · Boston Scientific Corp · Oct 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · Arthrocare Corp. · Mar 2001
RAPID EXCHANGE TAPERTOME
K002802 · Boston Scientific Corp · Oct 2000