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FDA 510(k)

Hubly Drill (H100)

K-Number: K250815 · 2025-11-06

ApplicantHubly, Inc.
Decision Date2025-11-06
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Hubly Drill (H100) is a medical device manufactured by Hubly, Inc.. It received FDA 510(k) clearance on 2025-11-06 under approval 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. It is manufactured by Hubly, Inc.. The 510(k) number is K250815.

When was Hubly Drill (H100) approved by the FDA?

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

What company makes Hubly Drill (H100)?

Hubly Drill (H100) is manufactured by Hubly, Inc..

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

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

Other Devices by Hubly, Inc.

K230619Hubly Electric Drill (H100)

Related Devices (Code: HBE)

K161704Phasor DrillBiotex, Inc. K153519DRealCarevature Medical, Ltd. K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation K162542OsteoMed PINNACLE DriverOsteomed K172709ELAN 4 Electro Motor System ToolsAesculap, Inc. K182436POWEREASE SystemMedtronic Sofamor Danek USA, 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.

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