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FDA PMA

Drug coated prostatic dilation catheter for benign prostatic hyperplasia

Número do PMA: P220029 · 2025-12-15

RequerenteUrotronic, Inc.
Data da decisão2025-12-15
Número PMAP220029
Código do produtoQXB
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoGU

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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