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Data / Medical devices / United States / Hubly Surgical

Hubly Surgical: FDA-registered device maker in Lisle, IL, United States, 1 510(k) clearance

Hubly Surgical is registered with the FDA (registration 3029300352) in Lisle, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 4, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3029300352
Address
815 Ogden Ave, Lisle, IL, United States, 60532
Owner or operator
Hubly, Inc. (10088698)
Roles
Complaint file establishment, Specification developer
First device listed
October 4, 2023
Registered through
2027
Brand names listed
Hubly Electric Drill

Devices it lists

DeviceProduct codeClassRoleSource
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 4, 2023K230619Hubly Electric Drill (H100)HBESubstantially EquivalentHubly, Inc.accessdata.fda.gov

Compare with other makers

Updated May 4, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.