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

FDA 510(k)

Hubly Electric Drill (H100)

K-Number: K230619 · 2023-05-04

ApplicantHubly, Inc.
Decision Date2023-05-04
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Hubly Electric Drill (H100) is a medical device manufactured by Hubly, Inc.. It received FDA 510(k) clearance on 2023-05-04 under approval 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. It is manufactured by Hubly, Inc.. The 510(k) number is K230619.

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

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

What company makes Hubly Electric Drill (H100)?

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

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

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

Other Devices by Hubly, Inc.

K250815Hubly 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.

↑