Product Code: EMF FDA class 1 21 CFR 878.4800

Knife, Surgical

General, Plastic Surgery

The Surgical Knife is a general-purpose scalpel or blade handle used across surgical disciplines, including general and plastic surgery, to make precise incisions through tissue during operative procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EMF, regulated under 21 CFR 878.4800 in the General, Plastic Surgery (SU) specialty.

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510(k)s

FEI Numbers

222

Registration Numbers

222

Unique Applicants

Years Active

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Basic Information

Product Code: EMF
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 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K080133	MOUNTABLE ENDOSCOPIC BLADE	Mar 13, 2008	Substantially Equivalent	A.M. Surgical, Inc.
K982142	MOUNTABLE ENDOSCOPIC KNIFE	Dec 30, 1998	Substantially Equivalent	A.M. Surgical, Inc.
K890217	MICROSURGICAL KNIVES	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890215	MICROSURGICAL SCARIFIER	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890214	MICROSURGERY RAZOR BLADE HOLDER	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K880094	VAN-TEC ENDOPYELOTOMY KNIFE	Feb 29, 1988	Substantially Equivalent	Van-Tec, Inc.
K863752	VALTRAC (BAR) REMOVER DEVICE	Oct 24, 1986	Substantially Equivalent	Davis & Geck, Inc.
K863549	REUSABLE/DISPOSABLE AUTOPSY KNIFE SET	Sep 30, 1986	Substantially Equivalent	Surgipath Medical Industries, Inc.
K861947	SURGICAL KNIFE	Jun 06, 1986	Substantially Equivalent	Sharpoint, Inc.
K854891	KNIFE	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K851784	27-210 PLASTER KNIFE (REINER)	Jun 20, 1985	Substantially Equivalent	Artiberia
K843497	SURGICAL KNIVES & PROBES	Oct 31, 1984	Substantially Equivalent	Eder Instrument Co, Inc.
K843371	VALVOTOMY KNIFE	Oct 25, 1984	Substantially Equivalent	Downs Surgical , Ltd.
K834197	JAKOBI SURG. INSTR- #11 38/39/45/46/67	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834184	H.R. JAKOBI SURG. INSTRUMENTS #11 38/67	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K832368	CHANGING METHOD OF STERILITY RELEASE	Oct 31, 1983	Substantially Equivalent	Devon Industries, Inc.
K821769	MICROKNIFE	Sep 14, 1982	Substantially Equivalent	Biological & Environmental Control Laboratories
K801585	HESSBURG-BFRRON TREPHINE	Oct 03, 1980	Substantially Equivalent	Precision Instruments, Inc.
K791286	WECK MICROSURGICAL KNIFE	Jul 24, 1979	Substantially Equivalent	Vista Medical Products, Inc.
K780991	PARALLEL BLADE MARKER	Oct 03, 1978	Substantially Equivalent	Nestor Engineering Associates, Inc.
K780989	DEVIN-NESTOR SQUARE KNIFE	Oct 03, 1978	Substantially Equivalent	Nestor Engineering Associates, Inc.