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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 a medical device manufactured by Zenflow, Inc.. It received FDA 510(k) clearance on 2025-09-23 under approval 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. It is manufactured by Zenflow, Inc.. The 510(k) number is K251140.

When was Zenflow Spring Scope approved by the FDA?

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

What company makes Zenflow Spring Scope?

Zenflow Spring Scope is manufactured by Zenflow, Inc..

What is the FDA product code for Zenflow Spring Scope?

The FDA product code for Zenflow Spring Scope is FAJ.

Related Clinical Trials

NCT07538622 Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry NOT_YET_RECRUITING

Other Devices by Zenflow, Inc.

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

Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

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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