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FDA 510(k)

GHAJAR GUIDE TWIST DRILL

K-Number: K875018 · 1988-01-28

ApplicantNeurodynamics, Inc.
Decision Date1988-01-28
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GHAJAR GUIDE TWIST DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Neurodynamics, Inc.. It received FDA 510(k) clearance on 1988-01-28 under 510(k) number K875018. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GHAJAR GUIDE TWIST DRILL?

GHAJAR GUIDE TWIST DRILL is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Neurodynamics, Inc.. The 510(k) number is K875018.

When did GHAJAR GUIDE TWIST DRILL receive FDA 510(k) clearance?

GHAJAR GUIDE TWIST DRILL received FDA 510(k) clearance on 1988-01-28, under 510(k) number K875018.

Who is the listed applicant for GHAJAR GUIDE TWIST DRILL?

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 TWIST DRILL?

The FDA product code for GHAJAR GUIDE TWIST DRILL is HBG.

Related Clinical Trials

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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 CATHETERK875019GHAJAR GUIDE SYSTEM FOR THE PERFORATOR

Related Devices (Code: HBG)

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.

K252696LEGACYPhasor Health, LLCK153587Taps for Resorbable ScrewsSynthes (USA) Products, LLCK162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.K122456MRII CRAINIAL DRILLMri Interventions, Inc.K022712HAND DRILL, MODEL 11-9901-7Medical Design, LLC

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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