Cleared Traditional

Disposable Laryngeal Electrodes

K232888 · Suzhou Haishen Medical Device Associates Co., Ltd. · Ear, Nose, Throat
Dec 2023
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K232888 is an FDA 510(k) clearance for the Disposable Laryngeal Electrodes, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Suzhou Haishen Medical Device Associates Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 21, 2023, 94 days after receiving the submission on September 18, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K232888 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2023
Decision Date December 21, 2023
Days to Decision 94 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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