Product code FSE— General, Plastic Surgery

FDA has cleared 13 devices under product code FSE between 1976 and 1986, filed by 11 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.

• 19861 clearance
• 19842 clearances
• 19832 clearances
• 19822 clearances
• 19801 clearance
• 19791 clearance
• 19783 clearances
• 19761 clearance

• Devon Industries, Inc.3 clearances
• Tecnol New Jersey Wound Care, Inc.1 clearance
• Surgi-Quip Inc.U1 clearance
• Porex Medical1 clearance
• Orthopedic Systems, Inc.1 clearance
• Intl. Management Services, Inc.1 clearance
• Innovative Surgical Products, Inc.1 clearance
• Healthmate, Inc.1 clearance
• Emerson-Sack-Warner Corp.1 clearance
• Aspen Laboratories, Inc.1 clearance

• K860503 — THE POREX RETRACTOR TABLEPorex Medical·1986-03-13
• K843801 — MASON EQUIPMENT ORGANIZER & ASPENAspen Laboratories, Inc.·1984-10-25
• K840027 — OPERATING ROOM STANDHealthmate, Inc.·1984-02-04
• K831042 — CHEMONUCLEOLYSIS TABLE EXTENSIONOrthopedic Systems, Inc.·1983-05-16
• K830339 — IMSI/METRIPOND HAND OPERATING TABLEIntl. Management Services, Inc.·1983-04-12
• K822427 — SELF-CONTAINED MOBILE OPHTHAL. OPER. .Surgi-Quip Inc.U·1982-09-14
• K821924 — TABLE, OPERATING, FIELD 6530-00-709-8155Emerson-Sack-Warner Corp.·1982-07-13
• K801382 — DISPOSABLE SURGICAL HEAD SUPPORTInnovative Surgical Products, Inc.·1980-06-26
• K782092 — ARMBOARD CVER, DISPOSABLEAnago, Inc.·1979-01-10
• K780866 — CHEST ROLLS HOLDERDevon Industries, Inc.·1978-08-14
• K780867 — PAD HOLDER KITDevon Industries, Inc.·1978-08-14
• K780868 — CHEST ROLLSDevon Industries, Inc.·1978-08-14
• K760308 — I.V. SUPPORT, TECNOL ARMBOARDTecnol New Jersey Wound Care, Inc.·1976-08-11