510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964103Substantially Equivalent

Olympique Medical Support Hose and Stockings

Tournier-Bottu S.A., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964103 is the FDA 510(k) clearance record for OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS, a class II device, cleared for Tournier-Bottu S.A. on under FDA product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)). FDA records list one 510(k) clearance for Tournier-Bottu S.A. As of , FDA records show no recalls naming K964103.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Regulation
21 CFR 880.5780
Device class
Class II
Review panel
General Hospital
Applicant
Tournier-Bottu S.A. 15825 Shady Grove Rd., Rockville MD
510(k) summary
Statement
Third party review
No

Clearances, product code DWL

Trailing 12 months

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

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