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FDA 510(k)

Traus SSG10 Surgical System

K-Number: K233153 · 2024-09-20

ApplicantSaeshin Precision Co., Ltd.
Decision Date2024-09-20
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Traus SSG10 Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K233153. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Traus SSG10 Surgical System?

Traus SSG10 Surgical System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K233153.

When did Traus SSG10 Surgical System receive FDA 510(k) clearance?

Traus SSG10 Surgical System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K233153.

Who is the listed applicant for Traus SSG10 Surgical System?

The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Traus SSG10 Surgical System?

The FDA product code for Traus SSG10 Surgical System is HBC.

Other records listing Saeshin Precision Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical SolutionsK173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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