Product Code: GDX FDA class 1 21 CFR 878.4800

Scalpel, One-Piece

General, Plastic Surgery

The Scalpel, One-Piece (product code GDX) is a single-piece surgical cutting instrument with an integral handle and blade, used to make precise incisions through skin and tissue during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

158

Registration Numbers

158

Unique Applicants

Years Active

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Basic Information

Product Code: GDX
Device Class: FDA class 1
Regulation Number: 878.4800
Medical Specialty: General, Plastic Surgery
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 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K923689	SURGISTAR BLADES	Sep 09, 1992	Substantially Equivalent	Surgistar, Inc.
K921167	ULTRABLADE	Jul 30, 1992	Substantially Equivalent	Micron Technology, Inc.
K914086	ICAN CYLINDRICAL SPONGES	Oct 09, 1991	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K904505	CCI CORNEAL SCARIFIER	Apr 23, 1991	Substantially Equivalent	Buckman Co., Inc.
K905380	1-CUT ACL GRAFT KNIFE	Dec 13, 1990	Substantially Equivalent	Depuy, Inc.
K895682	VESSEL LOOPS	Oct 24, 1989	Substantially Equivalent	Applied Medical Technologies
K893033	MINI-DIAMOND KNIFE	May 26, 1989	Substantially Equivalent	L.A.B. Instruments
K880028	OMED DISPOSABLE SCALPEL	Jan 29, 1988	Substantially Equivalent	Oxboro Medical Intl., Inc.
K871894	KCK INDUSTRIES' SURGICAL INSTRUMENTS	Jun 23, 1987	Substantially Equivalent	Kck Industries
K863950	P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL	Oct 24, 1986	Substantially Equivalent	Precision Surgical Industries, Inc.
K863213	KEISEI SCALPEL (STERILE AND NON-STERILE)	Sep 02, 1986	Substantially Equivalent	Keisei Medical Industrial Co., Ltd.
K854857	SCALPEL, ONE-PIECE, DISPOSABLE	Dec 24, 1985	Substantially Equivalent	Medelec Intl. Corp.
K853103	MCKNIFE	Aug 06, 1985	Substantially Equivalent	Medical Dimensions
K851751	7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1	Jun 20, 1985	Substantially Equivalent	Artiberia
K834541	H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K833467	SURE-CUT	Jan 27, 1984	Substantially Equivalent	Diverse Technologies, Inc.
K830745	ADT DISPOSABLE SCALPEL W/STAINLESS STEEL	Apr 12, 1983	Substantially Equivalent	Lab Industries, Inc.
K822893	G.E.V. DISPOSABLE SCALPELS	Oct 22, 1982	Substantially Equivalent	Ascep, Inc.
K822749	PILLING DIAMOND KNIFE	Oct 06, 1982	Substantially Equivalent	Narco Scientific
K820869	DISPOSABLE #11 SCALPEL BLADE W/SHORT	May 05, 1982	Substantially Equivalent	Van-Tec, Inc.
K820730	MICRO CISE DIAMOND SCALPEL	Apr 09, 1982	Substantially Equivalent	CooperVision, Inc.
K813422	SCALPEL	Jan 05, 1982	Substantially Equivalent	Abco Dealers, Inc.
K811707	AXICUT DISPOSABLE SCALPEL	Jul 20, 1981	Substantially Equivalent	Neonatal Corp.
K800177	I.M. BLADES	Feb 11, 1980	Substantially Equivalent	Instrument Makar, Inc.
K790259	STERILE DISPOSABLE KNIFE	Feb 13, 1979	Substantially Equivalent	Intermedics, Inc.
K780998	SCALPEL	Jul 27, 1978	Substantially Equivalent	Isolab, Inc.