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FDA 510(k)

AUTOMATIC CRANIAL DRILL (PERFORATOR)

K-Number: K892866 · 1989-06-15

ApplicantAcra Cut, Inc.
Decision Date1989-06-15
Product CodeHBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC CRANIAL DRILL (PERFORATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Acra Cut, Inc.. It received FDA 510(k) clearance on 1989-06-15 under 510(k) number K892866. 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 AUTOMATIC CRANIAL DRILL (PERFORATOR)?

AUTOMATIC CRANIAL DRILL (PERFORATOR) is a medical device that received FDA 510(k) clearance on 1989-06-15. The listed applicant is Acra Cut, Inc.. The 510(k) number is K892866.

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

AUTOMATIC CRANIAL DRILL (PERFORATOR) received FDA 510(k) clearance on 1989-06-15, under 510(k) number K892866.

Who is the listed applicant for AUTOMATIC CRANIAL DRILL (PERFORATOR)?

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

What is the FDA product code for AUTOMATIC CRANIAL DRILL (PERFORATOR)?

The FDA product code for AUTOMATIC CRANIAL DRILL (PERFORATOR) is HBF.

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Other records listing Acra Cut, Inc. 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.

K032970ACRA-CUT XPRESS 120K944311ACRA-CUTK911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWEREDK911812ACRA-CUT WIRE PASS DRILLK910225BONE PAD REMOVERK910226DURAL DISSECTORS

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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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