510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K033615Substantially Equivalent

Wfsi's Reprocessed Compression Sleeve Devices

Wheaton Franciscan Services Inc., Supply Chain, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033615 is the FDA 510(k) clearance record for WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES, a class II device, cleared for Wheaton Franciscan Services Inc., Supply Chain on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list one 510(k) clearance for Wheaton Franciscan Services Inc., Supply Chain. As of , FDA records show no recalls naming K033615.

Clearance record

Decision date
Received
(88 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Wheaton Franciscan Services Inc., Supply Chain 1800 E. 900 S., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOW

Trailing 12 months
8 clearances under product code JOW in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JOW, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20261
August 20261
September 20261
October 20260