510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032387Substantially Equivalent

Trivex System

Smith & Nephew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032387 is the FDA 510(k) clearance record for TRIVEX SYSTEM, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code DWQ (Stripper, Vein, External). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show one recall naming K032387.

Clearance record

Decision date
Received
(86 days to decision)
Product code
DWQ Stripper, Vein, External
Regulation
21 CFR 870.4885
Device class
Class II
Review panel
Cardiovascular
Applicant
Smith & Nephew, Inc. 150 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWQ

Trailing 12 months

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

FDA records show no clearances under product code DWQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWQ, 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