Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Zethon, Ltd.. It received FDA 510(k) clearance on 2024-03-14 under 510(k) 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. The listed applicant is Zethon, Ltd.. The 510(k) number is K233958.

When did hekaDrill receive FDA 510(k) clearance?

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

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 ERL.

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.

K193630hekaDrill

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker CorporationK200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceKARL STORZ Endoscopy-America, Inc.

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.

↑