510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043234Substantially Equivalent

Light Drape

Wrapped in Comfort, San Lorenzo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043234 is the FDA 510(k) clearance record for LIGHT DRAPE, a class II device, cleared for Wrapped IN Comfort on under FDA product code MMP (Cover, Barrier, Protective). FDA records list 2 510(k) clearances for Wrapped IN Comfort, from to . As of , FDA records show no recalls naming K043234.

Clearance record

Decision date
Received
(184 days to decision)
Product code
MMP Cover, Barrier, Protective
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Wrapped IN Comfort 15760 Via Sonata, San Lorenzo CA
510(k) summary
Statement
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