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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 the device name listed in this FDA 510(k) record. The listed applicant is Zethon, Ltd.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) 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. The listed applicant is Zethon, Ltd.. The 510(k) number is K193630.

When did hekaDrill receive FDA 510(k) clearance?

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

Who is the listed applicant for hekaDrill?

The FDA 510(k) record lists Zethon, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for hekaDrill?

The FDA product code for hekaDrill is HBC.

Other records listing Zethon, Ltd. 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.

K233958hekaDrill

Related Devices (Code: HBC)

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.

K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical SolutionsK173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA

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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