DeviceClearance

Product code KKX— General, Plastic Surgery

SURGICAL DRAPES

Classification name
Drape, Surgical, Antimicrobial
Device class
Class 2
Regulation
21 CFR 878.4370
Advisory panel
General, Plastic Surgery
Total cleared
450
First cleared
Most recent

FDA classification definition

“Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.”

— U.S. Food and Drug Administration, device classification record for product code KKX under 21 CFR 878.4370, via openFDA

Market context for product code KKX

FDA has cleared 450 devices under product code KKX between 1976 and 2023, filed by 252 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KKX

Recent clearances under product code KKX

1–100 of 450

Data sourced from openFDA. This site is unofficial and independent of the FDA.