Dilation Balloon Catheter

FDA 510(k) K253832 · Mirco-Tech (Nanjing) Co., Ltd.

Substantially Equivalent

510(k) numberK253832

Submission

Device name
Dilation Balloon Catheter
Applicant
Mirco-Tech (Nanjing) Co., Ltd.
Nanjing, CN
Received
December 1, 2025
Decision date
April 24, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FGE – Stents, Drains And Dilators For The Biliary Ducts
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5010
Specialty
Gastroenterology, Urology
Implant
Yes
Life-sustaining
Yes

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K253987BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional GIE Medical03/13/2026SE
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K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional Taewoong Medical Co., Ltd.12/29/2025SESU
K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional Bioteque Corporation12/22/2025SE
K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional Olympus Medical Systems Corporation10/21/2025SE
K251229EndoFix™Tissue Fixation SystemFGE · Traditional Softac Medical Technologies08/20/2025SE
K243412ARCHIMEDES Biodegradable Pancreatic StentFGE · Traditional Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)07/16/2025SE

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Questions and answers

When was Dilation Balloon Catheter cleared by the FDA?

Dilation Balloon Catheter (K253832) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 144 days after the submission was received.

What is the product code of K253832?

The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.