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FDA PMA

Drug coated prostatic dilation catheter for benign prostatic hyperplasia

PMA Number: P220029 · 2025-12-15

ApplicantUrotronic, Inc.
Decision Date2025-12-15
PMA NumberP220029
Product CodeQXB
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

Drug coated prostatic dilation catheter for benign prostatic hyperplasia is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2025-12-15. The device is classified under product code QXB. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Drug coated prostatic dilation catheter for benign prostatic hyperplasia?

Drug coated prostatic dilation catheter for benign prostatic hyperplasia is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Urotronic, Inc..

When did Drug coated prostatic dilation catheter for benign prostatic hyperplasia receive FDA 510(k) clearance?

The clearance date for Drug coated prostatic dilation catheter for benign prostatic hyperplasia can be found in the official FDA records.

Who is the listed applicant for Drug coated prostatic dilation catheter for benign prostatic hyperplasia?

The FDA 510(k) record lists Urotronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Drug coated prostatic dilation catheter for benign prostatic hyperplasia?

The FDA product code for Drug coated prostatic dilation catheter for benign prostatic hyperplasia is QXB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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