Product Code: GDF FDA class 1 21 CFR 878.4800

Guide, Needle, Surgical

General, Plastic Surgery

The Guide, Needle, Surgical (product code GDF) is a surgical accessory used to direct and control the path of a needle during procedures such as suturing, biopsy, or injection, improving precision and safety in general and plastic surgery. It is classified as FDA Class 1, posing minimal risk, subject only to general controls and not requiring 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

236

Registration Numbers

236

Unique Applicants

Years Active

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Basic Information

Product Code: GDF
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 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K031173	NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013	Jul 23, 2003	Substantially Equivalent	Needle Tech Products, Inc.
K950311	GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE	May 26, 1995	Substantially Equivalent	Global Medical Products, Ltd.
K950007	SURGICAL INSTRUMENT GUIDE	Mar 15, 1995	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K945124	BREAST LESION LOCALIZATION NEEDLE	Nov 22, 1994	Substantially Equivalent	Promex, Inc.
K944942	BREAST LESION LOCALIZATION NEEDLE	Nov 04, 1994	Substantially Equivalent	Promedical , Ltd.
K935538	BAUER TEMNO COAXIAL NEEDLE	Feb 22, 1994	Substantially Equivalent	Bauer Medical, Inc.
K935457	LOCALIZATION WIRE OR MARKER - SURGICAL	Feb 17, 1994	Substantially Equivalent	Bip USA, Inc.
K923840	NEEDLE-GRABBER	Jul 13, 1993	Substantially Equivalent	Guardian Angel Products, Inc.
K923835	THE ELEVENTH FINGER	Jul 09, 1993	Substantially Equivalent	Guardian Angel Products, Inc.
K925875	HORIZONTAL NEEDLE GUIDE ATTACHMENT	Apr 06, 1993	Substantially Equivalent	Bip USA, Inc.
K924270	BREAST LESION LOCALIZATION NEEDLE	Sep 23, 1992	Substantially Equivalent	Core Medical, Inc.
K923120	MICROGUIDE LESION MARKING SYSTEM	Sep 01, 1992	Substantially Equivalent	Angiodynamics, Div. E-Z-Em, Inc.
K914941	SIMON BREAST LESION LOCALIZATION NEEDLE	May 14, 1992	Substantially Equivalent	Manan Medical Products, Inc.
K920816	PERCUGUIDE LESION MARKING	Apr 21, 1992	Substantially Equivalent	E-Z-Em, Inc.
K904172	ACCUPLACE (TM)	Nov 21, 1990	Substantially Equivalent	Dlp, Inc.
K900903	KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE	May 03, 1990	Substantially Equivalent	Milex Products, Inc.
K890229	SURGICAL NEEDLE HOLDERS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890228	SURGICAL NEEDLE GUIDE	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890211	MICROSURGICAL NEEDLE HOLDERS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K882036	WILLIAMS ACS MARKER NEEDLE	Jul 27, 1988	Substantially Equivalent	Buckman Co., Inc.
K864551	BIOPSY ADAPTER #H4221BG	Dec 23, 1986	Substantially Equivalent	General Electric Co.
K863090	PERCU GUIDE I (LOOP TYPE)	Aug 29, 1986	Substantially Equivalent	E-Z-Em, Inc.
K861050	BIOPSY ADAPTER H4222W	Apr 02, 1986	Substantially Equivalent	General Electric Co.
K845038	BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT	Mar 11, 1985	Substantially Equivalent	Ranfac, Corp.
K832978	MENISCAL SUTURE GUN	Dec 12, 1983	Substantially Equivalent	Instrument Makar, Inc.
K821354	CONPHAR MAYO HEGAR NEEDLE HOLDER	Jun 03, 1982	Substantially Equivalent	Conphar, Inc.
K821295	OLSEN HEGAR NEEDLE HOLDERS	Jun 03, 1982	Substantially Equivalent	Conphar, Inc.
K821289	MAYO-HEGAR NEEDLE HOLDER	Jun 03, 1982	Substantially Equivalent	Conphar, Inc.