510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032105Substantially Equivalent

Endohelix Endarterectomy Device

Endarx, Inc., Portola Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032105 is the FDA 510(k) clearance record for ENDOHELIX ENDARTERECTOMY DEVICE, a class II device, cleared for Endarx, Inc. on under FDA product code DWX (Stripper, Artery, Intraluminal). FDA records list one 510(k) clearance for Endarx, Inc. As of , FDA records show no recalls naming K032105.

Clearance record

Decision date
Received
(114 days to decision)
Product code
DWX Stripper, Artery, Intraluminal
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Endarx, Inc. 3270 Alpine Rd., Portola Valley CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWX

Trailing 12 months

FDA records hold no clearances under product code DWX in the trailing twelve months.

FDA records show no clearances under product code DWX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260