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FDA 510(k)

Surgical Power System

K-Number: K254174 · 2026-09-11

ApplicantGuizhou Zirui Technology Co., Ltd.
Decision Date2026-09-11
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Surgical Power System is the device name listed in this FDA 510(k) record. The listed applicant is Guizhou Zirui Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K254174. 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 Surgical Power System?

Surgical Power System is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Guizhou Zirui Technology Co., Ltd.. The 510(k) number is K254174.

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

Surgical Power System received FDA 510(k) clearance on 2026-09-11, under 510(k) number K254174.

Who is the listed applicant for Surgical Power System?

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

What is the FDA product code for Surgical Power System?

The FDA product code for Surgical Power System is HBC.

Other records listing Guizhou Zirui Technology 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.

K254177Disposable Sterile Skull Drill (LZ)

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.

K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.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 Solutions

Official Source

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

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