Product Code: FPX FDA class 1 21 CFR 880.5240

Strip, Adhesive, Closure, Skin

General Hospital

The Adhesive Skin Closure Strip is a sterile strip with a pressure-sensitive adhesive applied across wound edges to hold them together during healing, serving as an alternative or supplement to sutures or staples for minor wound closure. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FPX, regulated under 21 CFR 880.5240 in the General Hospital specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FPX
Device Class: FDA class 1
Regulation Number: 880.5240
Medical Specialty: General Hospital
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K970441	K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH	May 09, 1997	Substantially Equivalent	Medi-Flex Hospital Products, Inc.
K952947	DELPORE SKIN CLOSURE	Jul 24, 1995	Substantially Equivalent	Bitco Intl.
K952702	DERMA SEAL	Jun 28, 1995	Substantially Equivalent	Ttl Medical
K946321	BIOSTRIP STERILE WOUND CLOSURE STRIP	Jan 12, 1995	Substantially Equivalent	Cornelia Damsky, Inc.
K931005	DUKAL SKIN CLOSURE STRIP	Jul 14, 1993	Substantially Equivalent	Dukal Corp.
K921775	SPYROFLEX WOUND CLOSURES	May 19, 1992	Substantially Equivalent	Polymint Industrial Co. , Ltd.
K894802	AWC BUTTERFLY WOUND CLOSURES	Jan 31, 1990	Substantially Equivalent	American White Cross, Inc.
K894205	TECNOL SILK STRIP	Jul 25, 1989	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K874813	OMED WOUND CLOSURE STRIPS	Jan 29, 1988	Substantially Equivalent	Oxboro Medical Intl., Inc.
K840945	SKIN CLOSURE	Oct 31, 1984	Substantially Equivalent	Gainor Medical
K842621	SUTURE STRIP	Oct 25, 1984	Substantially Equivalent	Genetic Laboratories, Inc.
K833258	SKIN TECH. SURGI-STRIPS	Jan 25, 1984	Substantially Equivalent	Lee Tec Corp.
K833083	DERMA STRIP-TM SKIN CLOSURES	Dec 30, 1983	Substantially Equivalent	Howmedica Corp.
K831438	ELASTOPLAST	Nov 25, 1983	Substantially Equivalent	Beiersdorf, Inc.
K831439	ELASTOPLAST T.P.N.	Sep 29, 1983	Substantially Equivalent	Beiersdorf, Inc.
K821763	SHUR-STRIP APPLICATOR	Jun 23, 1982	Substantially Equivalent	Shur Medical Corp.
K802385	CUSTOM DRESSING TRAY-WET TO DRY/MASS.	Nov 12, 1980	Substantially Equivalent	American Medical Disposable, Inc.
K802384	CENTRAL VENOUS CATHETER DRESSING TRAY	Nov 12, 1980	Substantially Equivalent	American Medical Disposable, Inc.
K801837	PLASTIC STRIP BANDAGES	Oct 31, 1980	Substantially Equivalent	Martin'S Maine Exchange
K801884	OP-SITE SKIN CLOSURE SUTURE ADHESIVE	Oct 10, 1980	Substantially Equivalent	Acme United Corp.
K792725	FIXOMULL	Mar 05, 1980	Substantially Equivalent	Beiersdorf, Inc.
K792726	LEUKOFIX POROS	Feb 28, 1980	Substantially Equivalent	Beiersdorf, Inc.
K792667	LEUKOCLIP POROS	Jan 16, 1980	Substantially Equivalent	Beiersdorf, Inc.
K792136	HYPO-ALLERGENIC PLASTIC TAPE	Jan 16, 1980	Substantially Equivalent	National Patent Development Corp.
K792360	HANSAPOR STERILE	Dec 31, 1979	Substantially Equivalent	Beiersdorf, Inc.
K790140	SKIN CLOSURE TAPES STERILE	Feb 27, 1979	Substantially Equivalent	Shur Medical Corp.
K782003	BAND AID* ADHESIVE BANDAGES	Jan 17, 1979	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K781952	PAPER TAPE, HYPO ALLERGENIC	Dec 07, 1978	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K780565	SUTURELESS SKIN CLOSURE	Jul 07, 1978	Substantially Equivalent	Abbott Laboratories
K772020	CLOTH ADHESIVE TAPE	Nov 02, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K771125	POLYURETHANE PROD. FOR I.V. NEEDLES	Aug 02, 1977	Substantially Equivalent	Devon Industries, Inc.
K770533	BAND-AID BRAND ADHES. BAND.-SHEER STRIPS	Jun 07, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K770081	BAND-AID BRAND OF ADHESIVE BANDAGES	Mar 09, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K770339	BANDAGE, PLASTIC & SHEER	Feb 28, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K770180	SUB. OF DIACETONE ACRYLAMIDE	Feb 15, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.