Cleared Traditional

K232938 - Traus SSG30 Surgical System

K232938 is an FDA 510(k) clearance for Traus SSG30 Surgical System, manufactured by Saeshin Precision Co., Ltd.. The device is a Class 2 Neurology device with product code HBC cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K232938 · Saeshin Precision Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2024
Decision
362d
Days
Class 2
Risk

K232938 is an FDA 510(k) clearance for the Traus SSG30 Surgical System. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 16, 2024 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Saeshin Precision Co., Ltd. devices

FDA 510(k) Submission Details - K232938

510(k) Number K232938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 148d · This submission: 362d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBC Device Classification - Class 2, Special Controls

Product Code HBC Motor, Drill, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4360
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 Neurology devices follow this clearance model.

Regulatory Consultant

E & M
Sanghwa Myung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HBC Motor, Drill, Electric

All 16
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