NAVIX ACCESS DEVICE— 510(k) K093279

Name: FDA 510(k) clearance K093279
Creator: U.S. Food and Drug Administration
Published: 2010-04-07

Substantially Equivalent

Xlumena

FDA 510(k) clearance K093279 for NAVIX ACCESS DEVICE, Substantially Equivalent on 2010-04-07. Applicant: Xlumena. Device class: 2.

Clearance details

Applicant: Xlumena
Product code: Code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-20
Decision date: 2010-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCJ

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K093279

K-number listed on FDA's recall record

Z-2167-2013 — Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.Class II·Terminated·Xlumena, Inc.·20130417

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093279.

Data sourced from openFDA. This site is unofficial and independent of the FDA.