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Turbt-Rf Electrodes And Electrosurgical Devices

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050488

by Prosurg Inc

Identifiers

510(k) Number
K050488 FDA 510(k)
FDA Product Code
FAS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4300 FDA 510(k)
Regulation Number
876.4300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Turbt-Rf Electrodes And Electrosurgical Devices by Prosurg Inc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Prosurg Inc
FDA Applicant
Prosurg, Inc.

Sources (1)

  • FDA 510(k) K050488 24 fields · synced Jun 18, 2026