Product code MKY— General, Plastic Surgery

FDA has cleared 6 devices under product code MKY between 1994 and 2001, 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.

• 20011 clearance
• 19981 clearance
• 19972 clearances
• 19942 clearances

• Progressive Surgical Products, Inc.3 clearances
• Wisebands , Ltd.1 clearance
• Phoenix Biomedical Corp.1 clearance
• Life Medical Sciences, Inc.1 clearance

• K002315 — WISEBANDS SKIN CLOSURE DEVICEWisebands , Ltd.·2001-03-15
• K982439 — PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.·1998-09-08
• K970439 — PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.·1997-04-16
• K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.·1997-01-14
• K942425 — PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.·1994-11-04
• K942526 — SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMLife Medical Sciences, Inc.·1994-07-19