DeviceClearance

Product code MCZ— General, Plastic Surgery

SUTURE REMOVAL KIT

Classification name
Suture Removal Kit
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
15
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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 MCZ under 21 CFR 878.4800, via openFDA

Market context for product code MCZ

FDA has cleared 15 devices under product code MCZ between 1981 and 2005, filed by 13 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code MCZ

Recent clearances under product code MCZ

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