Cleared Special

PLASMA EDGE System

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

About This 510(k) Submission

K240504 is an FDA 510(k) clearance for the PLASMA EDGE System, a Electrode, Electrosurgical, Active, Urological (Class II — Special Controls, product code FAS), submitted by Lamidey Noury Medical (Verri?res Le Buisson, FR). The FDA issued a Cleared decision on June 12, 2024, 112 days after receiving the submission on February 21, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K240504 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FAS — Electrode, Electrosurgical, Active, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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