PXUClass I

Fluid Drainage Tray

General, Plastic Surgery · 21 CFR 878.4200

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 events15All time

Recalls1All time

Registered firms21Currently listed

510(k) clearances0All time

Recent MDR events

15 adverse event reports on file

Event type breakdown

Injury11

Death2

Malfunction2

Most-reported manufacturers

Merit Medical Richmond6 Merit Medical Systems3 Merit Medical Systems Inc.3 Merit Medical Systems, Inc.3

Recalls

1 recall events for this product code

Merit Medical Systems, Inc.
Open, ClassifiedAug 12, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2569-2024 · View FDA record ↗

Registered firms

21 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.