Cleared Traditional

K061541 - KSEA BIPOLAR ELECTROTOME

K061541 is an FDA 510(k) clearance for KSEA BIPOLAR ELECTROTOME, manufactured by Ksea. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K061541 · Ksea · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
77d
Days
Class 2
Risk

K061541 is an FDA 510(k) clearance for the KSEA BIPOLAR ELECTROTOME. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Ksea (Culver City, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ksea devices

FDA 510(k) Submission Details - K061541

510(k) Number K061541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date August 21, 2006
Days to Decision 77 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
54d faster than avg
Panel avg: 131d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

Product Code FAS Electrode, Electrosurgical, Active, Urological
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 - FAS Electrode, Electrosurgical, Active, Urological

All 47
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