Product Code: GDM FDA class 1 21 CFR 878.4800

Needle, Aspiration And Injection, Reusable

General, Plastic Surgery

The Needle, Aspiration And Injection, Reusable (product code GDM) is a reusable needle used to aspirate fluid from or inject fluid into tissue or body cavities during general or plastic surgery, designed for sterilization and reuse across procedures. It is classified as FDA Class 1, posing minimal risk, 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

113

Registration Numbers

113

Unique Applicants

Years Active

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Basic Information

Product Code: GDM
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
K071732	MARROWMINER	Sep 24, 2007	Substantially Equivalent	Stemcor Systems, Inc.
K971114	BIOACCESS MARROW HARVEST SYSTEM	Jun 03, 1997	Substantially Equivalent	Bioaccess, Inc.
K953082	ILIAC CREST BONE MARROW ASPIRATION NEEDLE	Sep 22, 1995	Substantially Equivalent	Baxter Healthcare Corp
K953064	BIOACCESS MARROW HARVEST SYSTEM	Aug 07, 1995	Substantially Equivalent	Bioaccess, Inc.
K936207	ENDO-NEEDLE INSTRUMENT	Jun 16, 1994	Substantially Equivalent	Gerard Medical, Inc.
K930160	ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE	Jul 06, 1993	Substantially Equivalent	Symbiosis Corp.
K923872	BONE MARROW BIOPSY SYSTEM	Dec 15, 1992	Substantially Equivalent	The Straumann Co.
K915572	BECTON DICKINSON MODIFIED MENGHINI NEEDLE	Feb 03, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K904667	NA NEEDLES	Dec 12, 1990	Substantially Equivalent	Olympus Corp.
K903750	ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E	Oct 31, 1990	Substantially Equivalent	Downs Surgical , Ltd.
K903749	ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U	Oct 31, 1990	Substantially Equivalent	Downs Surgical , Ltd.
K903748	ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V	Oct 31, 1990	Substantially Equivalent	Downs Surgical , Ltd.
K903747	ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U	Oct 31, 1990	Substantially Equivalent	Downs Surgical , Ltd.
K902177	MANAN BONE BIOPSY NEEDLE	Sep 05, 1990	Substantially Equivalent	Manan Medical Products, Inc.
K901995	PLEURA BIOPSY DEVICE	Jul 10, 1990	Substantially Equivalent	Mill-Rose Laboratory
K895752	DIAMOND BLADE SURGICAL KNIVES	Oct 17, 1989	Substantially Equivalent	Magnum Diamond, Inc.
K895594	SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE	Oct 06, 1989	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K895551	ROCKET BONE MARROW NEEDLE	Oct 06, 1989	Substantially Equivalent	A & A Medical, Inc.
K890722	ADG BONE BIOPSY SYSTEM	Sep 21, 1989	Substantially Equivalent	American Design Group, Inc.
K891537	CORE BIOPSY NEEDLE, CATALOG CODE #54006	Apr 18, 1989	Substantially Equivalent	Dlp, Inc.
K885283	ASPIRATING AND IRRIGATING CYSTS NEEDLES	Mar 22, 1989	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K881784	KLEIN NEEDLE	Dec 02, 1988	Substantially Equivalent	E.L. Medico Intl., Inc.
K881783	KLEIN HANDLE	Dec 02, 1988	Substantially Equivalent	E.L. Medico Intl., Inc.
K883876	WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE	Oct 07, 1988	Substantially Equivalent	E.G. Dick & Assoc.
K881624	PLEURAL BIOPSY PUNCH NEEDLE	Aug 11, 1988	Substantially Equivalent	E.G. Dick & Assoc.
K882240	STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC	Jul 29, 1988	Substantially Equivalent	Storz Instrument Co.
K882601	E-Z-EM(R) LUFKIN BIOPSY NEEDLES	Jul 25, 1988	Substantially Equivalent	E-Z-Em, Inc.
K882073	SPINAL NEEDLE	Jul 18, 1988	Substantially Equivalent	Karlin Technology, Inc.
K881730	BREAST LOCALIZATION NEEDLES	May 13, 1988	Substantially Equivalent	Hart Enterprises, Inc.
K880812	SPINAL NEEDLE	Mar 11, 1988	Substantially Equivalent	T. Korossurgical Instruments Corp.
K874928	WHOLEY (TM) BIOPSY DEVICE	Dec 30, 1987	Substantially Equivalent	Medrad, Inc.
K873848	RETROBULBAR NEEDLE	Oct 23, 1987	Substantially Equivalent	Healthtek, Inc.
K870523	HAWKINS BREAST LOCALIZATION NEEDLE	Mar 09, 1987	Substantially Equivalent	N-S Medical Products
K864193	GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN	Nov 17, 1986	Substantially Equivalent	Gaw, Inc.
K862805	ANGIOMED VAC-U-CUT BIOPSY NEEDLE	Sep 29, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K862749	LS9000 SUCTION BIOPSY NEEDLE	Sep 15, 1986	Substantially Equivalent	Engineering, Inc.
K862481	CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE	Jul 23, 1986	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.
K854420	MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL	Nov 22, 1985	Substantially Equivalent	Meadox Surgimed, Inc.
K843830	J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI	Oct 26, 1984	Substantially Equivalent	Popper & Sons, Inc.
K843690	ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE	Oct 25, 1984	Substantially Equivalent	Popper & Sons, Inc.
K833720	TRANSTHORACIC/TRANSABDOMINAL-TRAY	May 30, 1984	Substantially Equivalent	Applied Medical Devices, Inc.
K841299	BIERMAN BIOPSY NEEDLE	May 02, 1984	Substantially Equivalent	Popper & Sons, Inc.
K830235	FRANZEN NEEDLE GUIDE	Feb 23, 1983	Substantially Equivalent	Precision Dynamics Corp.
K820339	ISLAM BONE MARROW BIOPSY NEEDLE	Feb 23, 1982	Substantially Equivalent	Downs Surgical , Ltd.
K800406	FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE	Mar 12, 1980	Substantially Equivalent	A.D.T. Lab Industries
K791643	BONE MARROW NEEDLE	Sep 12, 1979	Substantially Equivalent	Johannah Medical Services, Inc.
K772293	BONE MARROW BIOPSY DEVICE	Jan 03, 1978	Substantially Equivalent	Radiation Development Co., Inc.
K771574	LEE ASPIRATION NEEDLE	Dec 06, 1977	Substantially Equivalent	Radiation Development Co., Inc.