Cranial Drill Bits and Accessories
K-Number: K170442 · 2017-09-07
Decision Date2017-09-07
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Cranial Drill Bits and Accessories is a medical device manufactured by Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2017-09-07 under approval 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. It is manufactured by Ad-Tech Medical Instrument Corporation. The 510(k) number is K170442.
When was Cranial Drill Bits and Accessories approved by the FDA?
Cranial Drill Bits and Accessories received FDA 510(k) clearance on 2017-09-07, under approval number K170442.
What company makes Cranial Drill Bits and Accessories?
Cranial Drill Bits and Accessories is manufactured by Ad-Tech Medical Instrument Corporation.
What is the FDA product code for Cranial Drill Bits and Accessories?
The FDA product code for Cranial Drill Bits and Accessories is HBE.
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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.