Product Code: ITG FDA class 1 21 CFR 890.3025

Bandage, Cast

Physical Medicine

A cast bandage is a bandage impregnated with a hardening material, typically plaster or synthetic resin, used to immobilize fractured bones or soft tissue injuries by creating a rigid external cast. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITG, regulated under 21 CFR 890.3025, within the Physical Medicine medical specialty. This device is GMP exempt.

View on FDA

510(k)s

FEI Numbers

239

Registration Numbers

239

Unique Applicants

Years Active

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Basic Information

Product Code: ITG
Device Class: FDA class 1
Regulation Number: 890.3025
Medical Specialty: Physical Medicine
Review Panel: PM
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 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K873111	CONFORMA(TM) PLASTER BANDAGES	Oct 09, 1987	Substantially Equivalent	The Kendal Co.
K862115	DEKNA BAND KIT	Aug 19, 1986	Substantially Equivalent	Deknatel, Inc.
K842573	T.P.G. CAST TAPE	Aug 10, 1984	Substantially Equivalent	The Poly Group, Inc.
K840416	HEXCELITE	Mar 23, 1984	Substantially Equivalent	Hexcel Medical
K833732	NON WETTING UNDERCAST PADDING	Dec 12, 1983	Substantially Equivalent	American Medical Disposable, Inc.
K832992	SOFFBAN ORTHOPEDIC PADDING	Nov 14, 1983	Substantially Equivalent	Smith & Nephew, Inc.
K832237	ORTHOPEDIC CASTING TAPE MAXCAST	Aug 16, 1983	Substantially Equivalent	Cutter Laboratories, Inc.
K830650	SUPPORT PRODUCTS EXAMPLE PROSET CAST	Jul 07, 1983	Substantially Equivalent	Isopedix Corp.
K831492	YESONA PLASTER OF PARIS BANDAGE	Jun 30, 1983	Substantially Equivalent	Watson Phillips Y Cia. Sucs., S.A. DE C.V.
K820890	URETHANE ORTHOPAEDIC CASTING TAPE	Jun 23, 1982	Substantially Equivalent	Hexcel Medical
K820155	SPECIALIST CAST PADDING	Feb 12, 1982	Substantially Equivalent	Stan-Pak Ent.
K820140	WEBRIL CAST PADDING	Feb 12, 1982	Substantially Equivalent	Stan-Pak Ent.
K813052	ULTRACAST WATERLESS SYNTHETIC RESIN CAST	Feb 04, 1982	Substantially Equivalent	Zimmer, Inc.
K813219	CARAFLEX ELASTIC POLYMER PLASTER BANDA	Dec 17, 1981	Substantially Equivalent	Carapace, Inc.
K811754	CRYSTONA	Jul 20, 1981	Substantially Equivalent	Smith & Nephew, Inc.
K811164	URETHANE ORTHOPAEDIC CASTING TAPE	May 27, 1981	Substantially Equivalent	Hexcel Medical
K810877	ORTHOSIS BANDAGES	Apr 17, 1981	Substantially Equivalent	Ortho-Cast, Inc.
K810111	CELLONA PLASTER VARNISH	Feb 04, 1981	Substantially Equivalent	Secol Co.
K802792	CELLONA	Dec 10, 1980	Substantially Equivalent	Secol Co.
K802796	CELLAMIN	Nov 24, 1980	Substantially Equivalent	Secol Co.
K800749	IPOCON 7	Jul 28, 1980	Substantially Equivalent	Ipos Luneburg
K800695	BVN	May 02, 1980	Substantially Equivalent	Donald J. Mangus, M.D.
K800752	PRE-PADDED PLASTER/PARIS BAND/SPLINTS	Apr 21, 1980	Substantially Equivalent	Ortho-Care, Inc.
K800195	COTTON UNDER CAST PADDING	Feb 11, 1980	Substantially Equivalent	Winn Hirsch & Assoc.
K791831	PROCAST	Sep 24, 1979	Substantially Equivalent	Medical Specialties, Inc.
K791305	FELTLOC CAST PADDING	Jul 30, 1979	Substantially Equivalent	Howmedica Corp.
K791094	3M ORTHOPEDIC CASTING TAPE	Jul 24, 1979	Substantially Equivalent	3M Company
K790320	DELTA-LITE	May 18, 1979	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K771452	CONFORM STRETCH BANDAGE (5SIZES)	Sep 12, 1977	Substantially Equivalent	Kendall Research Center
K770929	BANDAGES, SPEC. X-TRA HARD OR PLASTER	Jun 02, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K770742	CUTTER CAST 7	Apr 28, 1977	Substantially Equivalent	Cutter Laboratories, Inc.
K770340	BANDAGES, PLASTER OF PARIS & SPLINTS	Feb 28, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K770134	LIGHTCAST II STOCKINETTE	Jan 26, 1977	Substantially Equivalent	Solar Laboratories, Inc.
K770133	LIGHTCAST II CASTING SYSTEM (MODIFIED)	Jan 26, 1977	Substantially Equivalent	Solar Laboratories, Inc.
K760841	HEXCELITE SHEET SPLINTS	Nov 01, 1976	Substantially Equivalent	Hexcel Medical
K760413	TAPE, LIGHTCAST II WB	Aug 23, 1976	Substantially Equivalent	Solar Laboratories, Inc.
K760003	CAST MATERIAL (WICKET STOCKINETTE)	Jul 26, 1976	Substantially Equivalent	Zimmer, Inc.