DeviceClearance

Product code PYE— General, Plastic Surgery

XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001

Classification name
Staple Removal Kit
Device class
Class 1
Regulation
21 CFR 878.4760
Advisory panel
General, Plastic Surgery
Total cleared
1
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 PYE under 21 CFR 878.4760, via openFDA

Market context for product code PYE

FDA has cleared 1 device under product code PYE, all in 1984, filed by 1 applicant company. 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.

Top applicants under product code PYE

Recent clearances under product code PYE

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