Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: GDM FDA class 1

Needle, Aspiration And Injection, Reusable

General, Plastic Surgery

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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.

510(k) Clearances

48 matches

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.

K903747

ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U

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.

K903750

ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E

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.

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.

K895551

ROCKET BONE MARROW NEEDLE

Oct 06, 1989

Substantially Equivalent

A & A MEDICAL, INC.

K895594

SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE

Oct 06, 1989

Substantially Equivalent

GO MEDICAL INDUSTRIES PTY. LTD.

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

GOMEDICAL 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. KOROS SURGICAL 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.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

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