510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K894071Substantially Equivalent

Comfort Sheer Firm and Sheer Support Pantyhose

Sara Lee Corp., Winston-Salem NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894071 is the FDA 510(k) clearance record for COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE, a class II device, cleared for Sara Lee Corp. on under FDA product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)). FDA records list one 510(k) clearance for Sara Lee Corp. As of , FDA records show no recalls naming K894071.

Clearance record

Decision date
Received
(132 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
Sara Lee Corp. 470 Hanes Mill Rd., Winston-Salem NC
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