DeviceClearance

Product code MCY— General Hospital

CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY

Classification name
Wound Dressing Kit
Device class
Class 2
Regulation
21 CFR 880.5075
Advisory panel
General Hospital
Total cleared
24
First cleared
Most recent

FDA classification definition

“This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

— U.S. Food and Drug Administration, device classification record for product code MCY under 21 CFR 880.5075, via openFDA

Market context for product code MCY

FDA has cleared 24 devices under product code MCY between 1990 and 1997, filed by 21 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

Top applicants under product code MCY

Recent clearances under product code MCY

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