510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140561Substantially Equivalent

Axios Stent and Delivery System (with 10Mm X 10Mm Stent) Axios Stent and Delivery System (with 15Mm X 10Mm Stent)

Xlumena, Inc., Mountain View CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140561 is the FDA 510(k) clearance record for AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT), a class II device, cleared for Xlumena, Inc. on under FDA product code PCU (Pancreatic Stent, Covered, Metallic, Removable). FDA's definition for product code PCU reads: "To facilitate transmural endoscopic drainage of pancreatic pseudocysts". FDA records list 3 510(k) clearances for Xlumena, Inc., from to . As of , FDA records show no recalls naming K140561.

Clearance record

Decision date
Received
(49 days to decision)
Product code
PCU Pancreatic Stent, Covered, Metallic, Removable
Regulation
21 CFR 876.5015
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Xlumena, Inc. 453 Ravendale Dr., Suite H, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCU

Trailing 12 months
1 clearance under product code PCU in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PCU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260