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FDA 510(k)

Dilation Balloon Catheter

K-Number: K253832 · 2026-04-24

ApplicantMirco-Tech (Nanjing) Co., Ltd.
Decision Date2026-04-24
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dilation Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K253832. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dilation Balloon Catheter?

Dilation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K253832.

When did Dilation Balloon Catheter receive FDA 510(k) clearance?

Dilation Balloon Catheter received FDA 510(k) clearance on 2026-04-24, under 510(k) number K253832.

Who is the listed applicant for Dilation Balloon Catheter?

The FDA 510(k) record lists Mirco-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dilation Balloon Catheter?

The FDA product code for Dilation Balloon Catheter is FGE.

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.

NCT06799052Cervical Preparation for Same-Day Dilation & EvacuationRECRUITINGNCT07583706A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic HyperplasiaRECRUITING

Other records listing Mirco-Tech (Nanjing) Co., Ltd. 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.

K260262Injection NeedleK254153Single-use Video Scope; PB Digital ControllerK253139Disposable Distal CapK233772Disposable Dual Action Tissue Closure Device

Related Devices (Code: FGE)

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.

K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019Hangzhou AGS MedTech Co., Ltd.K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbHK253987BARE Wireguided Balloon Dilation Catheter (1235)GIE MedicalK253132Single use stone retrieval balloonsZhejiang Chuangxiang Medical Technology Co., Ltd.K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.

Official Source

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