Product code FYE— General, Plastic Surgery

FDA has cleared 7 devices under product code FYE between 1989 and 1994, 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.

• 19941 clearance
• 19913 clearances
• 19893 clearances

• Unicor Federal Dept. of Justice1 clearance
• Protect Corp. of Indiana, Inc.1 clearance
• Johnson & Johnson Medical, Inc.1 clearance
• Intermedics Orthopedics1 clearance
• Depuy-Raynham1 clearance
• Clinitech, Inc.1 clearance
• Barrier Concepts, Inc.1 clearance

• K932731 — BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWNJohnson & Johnson Medical, Inc.·1994-04-11
• K912790 — SURGICAL GOWNUnicor Federal Dept. of Justice·1991-09-19
• K910920 — PROTEKT GLOVESIntermedics Orthopedics·1991-05-15
• K910941 — LIFELINER SURGICAL GLOVEDepuy-Raynham·1991-05-09
• K895667 — STERILE SURGICAL GOWNClinitech, Inc.·1989-10-13
• K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTSProtect Corp. of Indiana, Inc.·1989-09-19
• K894760 — CLOTHINGUARDBarrier Concepts, Inc.·1989-08-18