Cleared Traditional

Traus SSG10 Surgical System

K233153 · Saeshin Precision Co., Ltd. · Neurology
Sep 2024
Decision
359d
Days
Class 2
Risk

About This 510(k) Submission

K233153 is an FDA 510(k) clearance for the Traus SSG10 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 20, 2024, 359 days after receiving the submission on September 27, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K233153 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date September 20, 2024
Days to Decision 359 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

Similar Devices — HBC Motor, Drill, Electric

All 25
Traus SSG30 Surgical System
K232938 · Saeshin Precision Co., Ltd. · Sep 2024
ORiGO System
K213697 · Bien-Air Surgery SA · Oct 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
K220485 · The Anspach Effort, Inc. · May 2022
hekaDrill
K193630 · Zethon, Ltd. · Apr 2021
MR8 Drill System, Midas Rex MR8 ClearView Tools
K183515 · Medtronic Powered Surgical Solutions · May 2019
OSSEODUO Shaver and Drill System
K173066 · Bien-Air Surgery SA · Jun 2018