FDA 510(k)

Cranial Drill Bits and Accessories

K-Number: K170442 · 2017-09-07

ApplicantAd-Tech Medical Instrument Corporation

Decision Date2017-09-07

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cranial Drill Bits and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K170442. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cranial Drill Bits and Accessories?

Cranial Drill Bits and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K170442.

When did Cranial Drill Bits and Accessories receive FDA 510(k) clearance?

Cranial Drill Bits and Accessories received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170442.

Who is the listed applicant for Cranial Drill Bits and Accessories?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial Drill Bits and Accessories?

The FDA product code for Cranial Drill Bits and Accessories is HBE.

Other records listing Ad-Tech Medical Instrument Corporation 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.

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Related Devices (Code: HBE)

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.