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FDA 510(k)

hekaDrill

K-Number: K193630 · 2021-04-09

ApplicantZethon, Ltd.
Decision Date2021-04-09
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

hekaDrill is a medical device manufactured by Zethon, Ltd.. It received FDA 510(k) clearance on 2021-04-09 under approval number K193630. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the hekaDrill?

hekaDrill is a medical device that received FDA 510(k) clearance on 2021-04-09. It is manufactured by Zethon, Ltd.. The 510(k) number is K193630.

When was hekaDrill approved by the FDA?

hekaDrill received FDA 510(k) clearance on 2021-04-09, under approval number K193630.

What company makes hekaDrill?

hekaDrill is manufactured by Zethon, Ltd..

What is the FDA product code for hekaDrill?

The FDA product code for hekaDrill is HBC.

Other Devices by Zethon, Ltd.

K233958hekaDrill

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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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