FDA 510(k) clearance · back to tracker

BARE Wireguided Balloon Dilation Catheter (1235)

GIE Medical cleared K253987 on 2026-03-13, decision: substantially equivalent

K-number

K253987

Sponsor

GIE Medical

Device

BARE Wireguided Balloon Dilation Catheter (1235)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-03-13

Product code

FGE

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5010

Official FDA record

Open K253987on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.