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FDA 510(k)

hekaDrill

K-Number: K233958 · 2024-03-14

ApplicantZethon, Ltd.
Decision Date2024-03-14
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

hekaDrill is a medical device manufactured by Zethon, Ltd.. It received FDA 510(k) clearance on 2024-03-14 under approval number K233958. The device is classified under product code ERL. It was reviewed by the EN 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 2024-03-14. It is manufactured by Zethon, Ltd.. The 510(k) number is K233958.

When was hekaDrill approved by the FDA?

hekaDrill received FDA 510(k) clearance on 2024-03-14, under approval number K233958.

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 ERL.

Other Devices by Zethon, Ltd.

K193630hekaDrill

Related Devices (Code: ERL)

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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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