FDA 510(k)

Hubly Electric Drill (H100)

K-Number: K230619 · 2023-05-04

Decision Date2023-05-04

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Hubly Electric Drill (H100) is the device name listed in this FDA 510(k) record. The listed applicant is Hubly, Inc.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K230619. 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 Hubly Electric Drill (H100)?

Hubly Electric Drill (H100) is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Hubly, Inc.. The 510(k) number is K230619.

When did Hubly Electric Drill (H100) receive FDA 510(k) clearance?

Hubly Electric Drill (H100) received FDA 510(k) clearance on 2023-05-04, under 510(k) number K230619.

Who is the listed applicant for Hubly Electric Drill (H100)?

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

What is the FDA product code for Hubly Electric Drill (H100)?

The FDA product code for Hubly Electric Drill (H100) is HBE.

Other records listing Hubly, Inc. 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.

K250815Hubly Drill (H100)

Related Devices (Code: HBE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.