Cleared Traditional

Traus SSG30 Surgical System

K232938 · Saeshin Precision Co., Ltd. · Neurology
Sep 2024
Decision
362d
Days
Class 2
Risk

About This 510(k) Submission

K232938 is an FDA 510(k) clearance for the Traus SSG30 Surgical System, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 16, 2024, 362 days after receiving the submission on September 20, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K232938 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date September 16, 2024
Days to Decision 362 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBC — Motor, Drill, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4360

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