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FDA 510(k)

GHAJAR GUIDE SYSTEM FOR THE PERFORATOR

K-Number: K875019 · 1988-01-22

ApplicantNeurodynamics, Inc.
Decision Date1988-01-22
Product CodeHBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GHAJAR GUIDE SYSTEM FOR THE PERFORATOR is the device name listed in this FDA 510(k) record. The listed applicant is Neurodynamics, Inc.. It received FDA 510(k) clearance on 1988-01-22 under 510(k) number K875019. 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 GHAJAR GUIDE SYSTEM FOR THE PERFORATOR?

GHAJAR GUIDE SYSTEM FOR THE PERFORATOR is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Neurodynamics, Inc.. The 510(k) number is K875019.

When did GHAJAR GUIDE SYSTEM FOR THE PERFORATOR receive FDA 510(k) clearance?

GHAJAR GUIDE SYSTEM FOR THE PERFORATOR received FDA 510(k) clearance on 1988-01-22, under 510(k) number K875019.

Who is the listed applicant for GHAJAR GUIDE SYSTEM FOR THE PERFORATOR?

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

What is the FDA product code for GHAJAR GUIDE SYSTEM FOR THE PERFORATOR?

The FDA product code for GHAJAR GUIDE SYSTEM FOR THE PERFORATOR is HBF.

Related Clinical Trials

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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Other records listing Neurodynamics, 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.

K932402MODIFICATION TO GHAJAR GUIDE TWIST DRILLK875205TRI-FLOW CATHETERK875018GHAJAR GUIDE TWIST DRILL

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

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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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