Product code FXN— General, Plastic Surgery

FDA has cleared 4 devices under product code FXN between 1996 and 2013, filed by 4 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.

• 20132 clearances
• 20071 clearance
• 19961 clearance

• Woundvision, LLC1 clearance
• Verg, Inc.1 clearance
• Aranz Medical Limited1 clearance
• Advanced Planimetric Services, LLC1 clearance

• K131596 — WOUND MEASURING & MONITORING DEVICEWoundvision, LLC·2013-12-11
• K130165 — PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0Advanced Planimetric Services, LLC·2013-08-30
• K070426 — SILHOUETTE, MODEL 1000.01Aranz Medical Limited·2007-06-29
• K962148 — VERGE VIDEOMETERVerg, Inc.·1996-12-20