FDA 510(k)

Hubly Drill (H100)

K-Number: K250815 · 2025-11-06

Decision Date2025-11-06

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Hubly 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 2025-11-06 under 510(k) number K250815. 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 Drill (H100)?

Hubly Drill (H100) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Hubly, Inc.. The 510(k) number is K250815.

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

Hubly Drill (H100) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K250815.

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

The FDA product code for Hubly 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.

K230619Hubly Electric 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.