Pro-Tx Endorectal Balloon (PROT-25)— 510(k) K223249

Name: FDA 510(k) clearance K223249
Creator: U.S. Food and Drug Administration
Published: 2023-02-10

Substantially Equivalent

Dxtx Medical, Inc.

FDA 510(k) clearance K223249 for Pro-Tx Endorectal Balloon (PROT-25), Substantially Equivalent on 2023-02-10. Applicant: Dxtx Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dxtx Medical, Inc.
Product code: Code PCT
Device class: Class 2
Regulation: 21 CFR 892.5720
Advisory panel: Radiology
Date received: 2022-09-12
Decision date: 2023-02-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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