Product code FPX— General Hospital

FDA has cleared 35 devices under product code FPX between 1977 and 1997, filed by 22 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.

• 19971 clearance
• 19953 clearances
• 19931 clearance
• 19921 clearance
• 19901 clearance
• 19891 clearance
• 19881 clearance
• 19843 clearances
• 19833 clearances
• 19821 clearance
• 19808 clearances
• 19793 clearances
• 19782 clearances
• 19776 clearances

• Johnson & Johnson Professionals, Inc.7 clearances
• Beiersdorf, Inc.6 clearances
• Shur Medical Corp.2 clearances
• American Medical Disposable, Inc.2 clearances
• Ttl Medical1 clearance
• Tecnol New Jersey Wound Care, Inc.1 clearance
• Polymint Industrial Co. , Ltd.1 clearance
• Oxboro Medical Intl., Inc.1 clearance
• National Patent Development Corp.1 clearance
• Medi-Flex Hospital Products, Inc.1 clearance

• K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHMedi-Flex Hospital Products, Inc.·1997-05-09
• K952947 — DELPORE SKIN CLOSUREBitco Intl.·1995-07-24
• K952702 — DERMA SEALTtl Medical·1995-06-28
• K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIPCornelia Damsky, Inc.·1995-01-12
• K931005 — DUKAL SKIN CLOSURE STRIPDukal Corp.·1993-07-14
• K921775 — SPYROFLEX WOUND CLOSURESPolymint Industrial Co. , Ltd.·1992-05-19
• K894802 — AWC BUTTERFLY WOUND CLOSURESAmerican White Cross, Inc.·1990-01-31
• K894205 — TECNOL SILK STRIPTecnol New Jersey Wound Care, Inc.·1989-07-25
• K874813 — OMED WOUND CLOSURE STRIPSOxboro Medical Intl., Inc.·1988-01-29
• K840945 — SKIN CLOSUREGainor Medical·1984-10-31
• K842621 — SUTURE STRIPGenetic Laboratories, Inc.·1984-10-25
• K833258 — SKIN TECH. SURGI-STRIPSLee Tec Corp.·1984-01-25
• K833083 — DERMA STRIP-TM SKIN CLOSURESHowmedica Corp.·1983-12-30
• K831438 — ELASTOPLASTBeiersdorf, Inc.·1983-11-25
• K831439 — ELASTOPLAST T.P.N.Beiersdorf, Inc.·1983-09-29
• K821763 — SHUR-STRIP APPLICATORShur Medical Corp.·1982-06-23
• K802384 — CENTRAL VENOUS CATHETER DRESSING TRAYAmerican Medical Disposable, Inc.·1980-11-12
• K802385 — CUSTOM DRESSING TRAY-WET TO DRY/MASS.American Medical Disposable, Inc.·1980-11-12
• K801837 — PLASTIC STRIP BANDAGESMartin'S Maine Exchange·1980-10-31
• K801884 — OP-SITE SKIN CLOSURE SUTURE ADHESIVEAcme United Corp.·1980-10-10
• K792725 — FIXOMULLBeiersdorf, Inc.·1980-03-05
• K792726 — LEUKOFIX POROSBeiersdorf, Inc.·1980-02-28
• K792136 — HYPO-ALLERGENIC PLASTIC TAPENational Patent Development Corp.·1980-01-16
• K792667 — LEUKOCLIP POROSBeiersdorf, Inc.·1980-01-16
• K792360 — HANSAPOR STERILEBeiersdorf, Inc.·1979-12-31
• K790140 — SKIN CLOSURE TAPES STERILEShur Medical Corp.·1979-02-27
• K782003 — BAND AID* ADHESIVE BANDAGESJohnson & Johnson Professionals, Inc.·1979-01-17
• K781952 — PAPER TAPE, HYPO ALLERGENICJohnson & Johnson Professionals, Inc.·1978-12-07
• K780565 — SUTURELESS SKIN CLOSUREAbbott Laboratories·1978-07-07
• K772020 — CLOTH ADHESIVE TAPEJohnson & Johnson Professionals, Inc.·1977-11-02
• K771125 — POLYURETHANE PROD. FOR I.V. NEEDLESDevon Industries, Inc.·1977-08-02
• K770533 — BAND-AID BRAND ADHES. BAND.-SHEER STRIPSJohnson & Johnson Professionals, Inc.·1977-06-07
• K770081 — BAND-AID BRAND OF ADHESIVE BANDAGESJohnson & Johnson Professionals, Inc.·1977-03-09
• K770339 — BANDAGE, PLASTIC & SHEERJohnson & Johnson Professionals, Inc.·1977-02-28
• K770180 — SUB. OF DIACETONE ACRYLAMIDEJohnson & Johnson Professionals, Inc.·1977-02-15