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FDA 510(k)

Disposable Sterile Skull Drill (LZ)

K-Number: K254177 · 2026-09-11

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

Device Summary

Disposable Sterile Skull Drill (LZ) 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 K254177. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Sterile Skull Drill (LZ)?

Disposable Sterile Skull Drill (LZ) 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 K254177.

When did Disposable Sterile Skull Drill (LZ) receive FDA 510(k) clearance?

Disposable Sterile Skull Drill (LZ) received FDA 510(k) clearance on 2026-09-11, under 510(k) number K254177.

Who is the listed applicant for Disposable Sterile Skull Drill (LZ)?

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 Disposable Sterile Skull Drill (LZ)?

The FDA product code for Disposable Sterile Skull Drill (LZ) is HBF.

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.

K254174Surgical Power System

Related Devices (Code: HBF)

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.

K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KGK213228NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.K183581Codman Disposable PerforatorsIntegra Lifesciences Corp.

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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