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FDA 510(k)

CRANIAL PERFORATOR

K-Number: K082637 · 2008-12-22

ApplicantThe Anspach Effort, Inc.
Decision Date2008-12-22
Product CodeHBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIAL PERFORATOR is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2008-12-22 under 510(k) number K082637. 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 CRANIAL PERFORATOR?

CRANIAL PERFORATOR is a medical device that received FDA 510(k) clearance on 2008-12-22. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K082637.

When did CRANIAL PERFORATOR receive FDA 510(k) clearance?

CRANIAL PERFORATOR received FDA 510(k) clearance on 2008-12-22, under 510(k) number K082637.

Who is the listed applicant for CRANIAL PERFORATOR?

The FDA 510(k) record lists The Anspach Effort, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIAL PERFORATOR?

The FDA product code for CRANIAL PERFORATOR is HBF.

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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.

K254177Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd.K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KGK213228NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.K183581Codman Disposable PerforatorsIntegra Lifesciences Corp.K121253MERIDIAN CRANIAL PERFORATORAdeor Medical Technologies GmbHK082010STRYKER DISPOSABLE CRANIAL PERFORATOR BITStryker Ireland Ltd., Instruments Division

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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