FDA PMA

약涂层 전립선 확장 캐빈터, 양성 전립선 비대증용

PMA 번호: P220029 · 2025-12-15

신청자Urotronic, Inc.

결정일2025-12-15

PMA 번호P220029

제품 코드QXB

의료기기 등급등급 3

의학적 전문분야U

자문 위원회규제 정책: medical-regulatory-v1 GU

기기 요약

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.

자주 묻는 질문

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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