510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944198Substantially Equivalent

Surgical Microscope Drape

Hydro-Med Products, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944198 is the FDA 510(k) clearance record for SURGICAL MICROSCOPE DRAPE, a class II device, cleared for Hydro-Med Products, Inc. on under FDA product code MMP (Cover, Barrier, Protective). FDA records list 13 510(k) clearances for Hydro-Med Products, Inc., from to . As of , FDA records show no recalls naming K944198.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MMP Cover, Barrier, Protective
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Hydro-Med Products, Inc. 2930 Ladybird Ln., Dallas TX
510(k) summary
Summary
Third party review
No

Clearances, product code MMP

Trailing 12 months

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

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