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FDA 510(k)

Zenflow Spring Scope

K-Number: K251140 · 2025-09-23

ApplicantZenflow, Inc.
Decision Date2025-09-23
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Zenflow Spring Scope is the device name listed in this FDA 510(k) record. The listed applicant is Zenflow, Inc.. It received FDA 510(k) clearance on 2025-09-23 under 510(k) number K251140. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zenflow Spring Scope?

Zenflow Spring Scope is a medical device that received FDA 510(k) clearance on 2025-09-23. The listed applicant is Zenflow, Inc.. The 510(k) number is K251140.

When did Zenflow Spring Scope receive FDA 510(k) clearance?

Zenflow Spring Scope received FDA 510(k) clearance on 2025-09-23, under 510(k) number K251140.

Who is the listed applicant for Zenflow Spring Scope?

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 Zenflow Spring Scope?

The FDA product code for Zenflow Spring Scope is FAJ.

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.

NCT07538622Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System RegistryNOT_YET_RECRUITING

Other records listing Zenflow, Inc. as applicant

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.

PMA P250007STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT

Related Devices (Code: FAJ)

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

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