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Data / Medical devices / United States / Clearcam

Clearcam: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance

Clearcam is registered with the FDA (registration 3016804805) in Austin, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 19, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3016804805
Address
8000 Centre Park Dr 170, Austin, TX, United States, 78754
Owner or operator
ClearCam (10072510)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
April 29, 2020
Registered through
2026
Brand names listed
ClearCam Kelling System, ClearCam System, ClearScope, Kelling

Devices it lists

DeviceProduct codeClassRoleSource
Laparoscope, General & Plastic SurgeryGCJ2Complaint file establishment, Manufacturer, 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
February 19, 2020K200228ClearCam SystemGCJSubstantially EquivalentClearcam, LLCaccessdata.fda.gov

Compare with other makers

Updated February 19, 2020. 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.