510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K940327Substantially Equivalent

Intervent Allergen Exclusion Technology, Intervent Bedding System, Intervent Mattress Interliner, Interview Pillow

W. L. Gore & Associates, Inc., Flagstaff AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940327 is the FDA 510(k) clearance record for INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW, a class I device, cleared for W. L. Gore & Associates, Inc. on under FDA product code FMW (Cover, Mattress (Medical Purposes)). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K940327.

Clearance record

Decision date
Received
(32 days to decision)
Product code
FMW Cover, Mattress (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Applicant
W. L. Gore & Associates, Inc. 3750 W. Kiltie Ln. Dock-A, Flagstaff AR
510(k) summary
Summary
Third party review
No

Clearances, product code FMW

Trailing 12 months

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

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