Cleared Special

K240504 - PLASMA EDGE System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240504 · Lamidey Noury Medical · Gastroenterology & Urology device
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Jun 2024
Decision
112d
Days
Class 2
Risk

K240504 is an FDA 510(k) clearance for the PLASMA EDGE System. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Lamidey Noury Medical (Verrières Le Buisson, FR). The FDA issued a Cleared decision on June 12, 2024 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lamidey Noury Medical devices

Submission Details

510(k) Number K240504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2024
Decision Date June 12, 2024
Days to Decision 112 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 57
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