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FDA 510(k)

CRANIAL DRILL

K-Number: K000195 · 2000-04-20

ApplicantImage-Guided Neurologics, Inc.
Decision Date2000-04-20
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIAL DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Image-Guided Neurologics, Inc.. It received FDA 510(k) clearance on 2000-04-20 under 510(k) number K000195. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIAL DRILL?

CRANIAL DRILL is a medical device that received FDA 510(k) clearance on 2000-04-20. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K000195.

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

CRANIAL DRILL received FDA 510(k) clearance on 2000-04-20, under 510(k) number K000195.

Who is the listed applicant for CRANIAL DRILL?

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

What is the FDA product code for CRANIAL DRILL?

The FDA product code for CRANIAL DRILL is HBB.

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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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