BARE Wireguided Balloon Dilation Catheter (1235)— 510(k) K253987
Substantially EquivalentGIE Medical
FDA 510(k) clearance K253987 for BARE Wireguided Balloon Dilation Catheter (1235), Substantially Equivalent on 2026-03-13. Applicant: GIE Medical. Device class: 2.
Summary
GIE Medical's BARE Wireguided Balloon Dilation Catheter (1235) is filed under FGE, biliary duct stents, drains and dilators. The record doesn't list balloon sizes.
Class II, 21 CFR 876.5010. It was a Traditional 510(k), and Gastroenterology and Urology is both the classification panel and the review panel.
GIE Medical filed from Brooklyn Park, Minnesota. The decision came 91 calendar days after FDA received it (December 12, 2025 to March 13, 2026).
Clearance details
- Applicant
- GIE Medical
- Product code
- Product code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn Park, MN, US
Recent devices under product code FGE
view all- K254179 — Drainage Catheter
- K262913 — Protégé EverFlex Self-expanding Peripheral Stent System
- K260835 — ARCHIMEDES Biodegradable Stent (Medium)
- K253393 — Single-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-5251-128019
- K253832 — Dilation Balloon Catheter
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.