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FDA PMA

STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT

PMA Number: P250007 · 2025-12-11

ApplicantZenflow, Inc.
Decision Date2025-12-11
PMA NumberP250007
Product CodeMER
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT is the device name listed in this FDA 510(k) record. The listed applicant is Zenflow, Inc.. It received FDA 510(k) clearance on 2025-12-11. The device is classified under product code MER. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT?

STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is Zenflow, Inc..

When did STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT receive FDA 510(k) clearance?

The clearance date for STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT can be found in the official FDA records.

Who is the listed applicant for STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT?

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

What is the FDA product code for STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT?

The FDA product code for STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT is MER.

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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