inforMED
MCZClass I

Suture Removal Kit

General, Plastic Surgery · 21 CFR 878.4800

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.

MDR events44All time
Recalls16All time
Registered firms58Currently listed
510(k) clearances15All time

Recalls

16 recall events for this product code

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