Product Code: GES FDA class 1 21 CFR 878.4800

Blade, Scalpel

General, Plastic Surgery

The Scalpel Blade (product code GES) is a sterile, single-use or reusable surgical cutting instrument used universally in general and plastic surgery for making precise incisions in tissue. It is classified as an FDA Class 1 device, the lowest risk category, governed only by general controls and not requiring premarket notification. Regulated under 21 CFR 878.4800 and assigned to the General, Plastic Surgery specialty (SU), this device carries no special regulatory flags.

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510(k)s

FEI Numbers

300

Registration Numbers

300

Unique Applicants

Years Active

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Basic Information

Product Code: GES
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 48 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K032242	PERSONNA PLUS SAFETY SCALPEL SYSTEM	Sep 23, 2003	Substantially Equivalent	Omi Manufacturing Pty., Ltd.
K932998	EASY-ON	Aug 18, 1993	Substantially Equivalent	Devon Industries, Inc.
K923170	LOS ALAMOS RETRACTABLE KNIFE	Feb 18, 1993	Substantially Equivalent	Innovative Surgical Technology, Inc.
K915119	SCALPEL BLADE REMOVER (BLADEGARD)	May 05, 1992	Substantially Equivalent	Intergrated Visual, Inc.
K911913	PRECISION GLIDE - ENHANCED SURGICAL BLADE	May 13, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K900266	STERILE CARBON STEEL SURGICAL BLADE	Mar 01, 1990	Substantially Equivalent	Rahn Laboratories
K884862	ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE	Dec 27, 1988	Substantially Equivalent	Anchor Products Co.
K881638	SURGICAL BLADE	Jun 15, 1988	Substantially Equivalent	Far East Intl. Trading Corp.
K880244	SURGICAL BLADES	Feb 10, 1988	Substantially Equivalent	Ailee C/O Havel'S, Inc.
K873493	NINJA SCALPEL	Sep 24, 1987	Substantially Equivalent	Primrose Medical, Inc.
K873142	PERSONNA DISPOSABLE SCALPEL	Sep 04, 1987	Substantially Equivalent	American Safety Razor Co.
K863885	SABLE BLADES	Oct 24, 1986	Substantially Equivalent	Sable Industries
K863867	DEXTRA DISPOSABLE BLADES	Oct 24, 1986	Substantially Equivalent	Storz Instrument Co.
K863214	KEISEI MICRO-BLADES (STERILE AND NON-STERILE)	Sep 02, 1986	Substantially Equivalent	Keisei Medical Industrial Co., Ltd.
K863211	KEISEI SURGICAL BLADES (STERILE & NON-STERILE)	Sep 02, 1986	Substantially Equivalent	Keisei Medical Industrial Co., Ltd.
K855104	ANGIOMED SKIN FASCIA KNIFE	Jan 24, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K854860	BLADES, SCALPEL CARBON STEET	Dec 24, 1985	Substantially Equivalent	Medelec Intl. Corp.
K854859	BLADES, SCALPEL STAINLESS STEEL	Dec 24, 1985	Substantially Equivalent	Medelec Intl. Corp.
K854620	SURGICAL BLADES	Dec 17, 1985	Substantially Equivalent	Niraj Industries
K854561	BLADE, SCALPEL	Dec 02, 1985	Substantially Equivalent	Medelec Intl. Corp.
K853528	STAINLESS STEEL & CARBON STEEL STERILE BLADES	Sep 24, 1985	Substantially Equivalent	Abco Dealers, Inc.
K852661	APOLLO STERILE BLADES	Jul 11, 1985	Substantially Equivalent	Orthofab, Inc.
K852141	STERILE SURGICAL BLADES	Jun 13, 1985	Substantially Equivalent	Miltex Instrument Co.
K851157	SURGIMED - SURGICAL BLADES	Apr 25, 1985	Substantially Equivalent	Surgimed Corp.
K844759	SURGICAL SCALPEL BLADES & DISPOSABLES	Jan 18, 1985	Substantially Equivalent	Cross Country Paper Products Corp.
K844001	LANCE BLADES & SCALPELS	Nov 08, 1984	Substantially Equivalent	Perry, Div.
K841883	SURGEON'S BLADES STERILE BLADE	Jun 05, 1984	Substantially Equivalent	An-Med Intl.
K841320	PERCUTANEOUS TRIG. FINGER RELEASE KNIFE	Apr 24, 1984	Substantially Equivalent	Anapach Effort, Inc.
K834514	FASCIA CUTTER	Mar 12, 1984	Substantially Equivalent	Stryker Corp.
K834195	JAKOBI SURG. INSTRUMENTS #11 11/13/14	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834194	JAKOBI SURG. INSTRUMENTS #1 19/10/26	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834182	H.R. JAKOBI SURG. INSTRUMENTS #11 27/37	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K821737	DISP. MICROSURGICAL KNIVES	Jul 02, 1982	Substantially Equivalent	Coburn Optical Ind., Inc.
K812516	SURGICAL BLADES & SCAPELS (SMPL. W/510K)	Oct 02, 1981	Substantially Equivalent	Needle Industries(Usa), Inc.
K812526	MICRO BLADE II	Sep 16, 1981	Substantially Equivalent	Vxtra Corp.
K812160	MICROSURGICAL BLADE	Aug 31, 1981	Substantially Equivalent	Vxtra Corp.
K812071	RK IV SURGICAL BLADES	Aug 31, 1981	Substantially Equivalent	Santa Barbara Medco, Inc.
K810572	BLADE, HANDLE, SCALPEL FORCEPS, SURGERY	Mar 20, 1981	Substantially Equivalent	Technical Resources, Inc.
K781716	BLADE, 20 ANGLE/MICRO BLADE HOLDER	Oct 24, 1978	Substantially Equivalent	Edward Weck, Inc.
K771045	BLADES, SCALPEL	Jun 22, 1977	Substantially Equivalent	American Safety Razor Co.
K770800	HANDLES, BLADE, SURGICAL	May 06, 1977	Substantially Equivalent	Lukens Corp.
K770798	BLADES, SURGICAL, STERILE	May 06, 1977	Substantially Equivalent	Lukens Corp.
K770217	LANCE LTD. STERI. STITCH CUTTER BLADE	Mar 30, 1977	Substantially Equivalent	Aeroceuticals
K761322	SURGICAL BLADES	Jan 06, 1977	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K760605	LIGHTCAST II CARBIDE BLADE	Oct 05, 1976	Substantially Equivalent	Merck, Sharp & Dohme
K760364	HANDLE, SCALPEL, STAINLESS STEEL	Sep 13, 1976	Substantially Equivalent	Aeroceuticals
K760363	SCALPEL, SURGICAL, STERILE STAINLESS	Sep 13, 1976	Substantially Equivalent	Aeroceuticals
K760361	BLADE, SURGICAL SCALPEL, STERILE	Sep 13, 1976	Substantially Equivalent	Aeroceuticals