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FDA 510(k)

BARE Wireguided Balloon Dilation Catheter (1235)

K-Number: K253987 · 2026-03-13

ApplicantGIE Medical
Decision Date2026-03-13
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARE Wireguided Balloon Dilation Catheter (1235) is a medical device manufactured by GIE Medical. It received FDA 510(k) clearance on 2026-03-13 under approval number K253987. 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 BARE Wireguided Balloon Dilation Catheter (1235)?

BARE Wireguided Balloon Dilation Catheter (1235) is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by GIE Medical. The 510(k) number is K253987.

When was BARE Wireguided Balloon Dilation Catheter (1235) approved by the FDA?

BARE Wireguided Balloon Dilation Catheter (1235) received FDA 510(k) clearance on 2026-03-13, under approval number K253987.

What company makes BARE Wireguided Balloon Dilation Catheter (1235)?

BARE Wireguided Balloon Dilation Catheter (1235) is manufactured by GIE Medical.

What is the FDA product code for BARE Wireguided Balloon Dilation Catheter (1235)?

The FDA product code for BARE Wireguided Balloon Dilation Catheter (1235) is FGE.

Related Clinical Trials

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Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

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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