Product code FYH— General, Plastic Surgery

FDA has cleared 8 devices under product code FYH between 1980 and 1993, filed by 7 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.

• 19932 clearances
• 19891 clearance
• 19851 clearance
• 19841 clearance
• 19821 clearance
• 19811 clearance
• 19801 clearance

• Johnson & Johnson Professionals, Inc.2 clearances
• Trace Medical Equipment, Inc.1 clearance
• The Huxley Instrument Corp.1 clearance
• Orthopedic Systems, Inc.1 clearance
• Kut-Guard, Inc.1 clearance
• Johnson & Johnson Orthopaedics, Inc.1 clearance
• Compression Splint Products, Inc.1 clearance

• K925145 — TRACE MODEL #'S 840, 841, 842, 845Trace Medical Equipment, Inc.·1993-05-19
• K924984 — SPECIALIST(R) WALKERJohnson & Johnson Orthopaedics, Inc.·1993-02-01
• K895092 — KUT-SHIELDKut-Guard, Inc.·1989-09-26
• K852558 — SPLINTS(ALL TYPE)The Huxley Instrument Corp.·1985-07-02
• K843400 — HYDRO-SPLINT A SPONGE-COMPRESS DRESSCompression Splint Products, Inc.·1984-10-24
• K821693 — J & J DIP WATER ADDITIVEJohnson & Johnson Professionals, Inc.·1982-07-02
• K802522 — DELTA-LITE CASTING TAPE & SPLINTSJohnson & Johnson Professionals, Inc.·1981-01-08
• K801436 — ORTHOPEDIC LOWER EXTREMITY SUSPENSIONOrthopedic Systems, Inc.·1980-06-26