Consulting Wallah › Device Explorer › Syringes, needles & infusion › Soft-tissue biopsy needle, single-use
Device Explorer · FDA GUDID · GMDN 47540

Soft-tissue biopsy needle, single-use

A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is availa

US‑registered devices247in commercial distribution
Companies11labelers on GUDID
Single‑use99%of device records
Sterile97%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Argon Medical Devices, Inc.10944%
Möller Medical Gmbh10141%
Inrad146%
Customed Inc62%
Compass International52%
Scion Medical Techologies, Llc42%
Hakko Co.,Ltd.21%
Broncus Medical Inc.21%

Top labelers

CompanyDevicesShare
Argon Medical Devices, Inc.10944%
Möller Medical Gmbh10141%
Inrad146%
Customed Inc62%
Compass International52%
Scion Medical Techologies, Llc42%
Hakko Co.,Ltd.21%
Broncus Medical Inc.21%
H.S. Hospital Service Spa21%
Bioncise10%
Manan Medical Products, Inc.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Spirotome SpineSonopsy-C1Chiba needleGreene Style needleFranseen needleSpinal needleDisposable needle for reusable biopsy gun"Pro-Mag™ ""Short Throw"" Biopsy Needle"Spinal Biopsy NeedleTLAB Transjugular Liver Biopsy SystemTLAB Transjugular Liver Access Biopsy SystemACN™ Biopsy NeedlePro-Mag™ Biopsy NeedleWestcott Biopsy Needle with Echogenic TipWestcott Biopsy NeedleTrocar Biopsy Needle

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KNWInstrument, Biopsy232
KNWINSTRUMENT, BIOPSY8
GAANeedle, Aspiration And Injection, Disposable5
DYBIntroducer, Catheter4
GDFGUIDE, NEEDLE, SURGICAL4
FCGBiopsy Needle Kit2

GMDN & GCC registration

  • GMDN code 47540 · non‑implantable
  • Single‑use 99% · sterile 97% · Rx‑only 96% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 20Length (Millimeter) · 10Length (Centimeter) · 9

Use these as the dimensions to specify in a tender line.

How many soft-tissue biopsy needle, single-use products are registered in the US?

247 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Soft-tissue biopsy needle, single-use", from 11 companies. The largest labeler is Argon Medical Devices, Inc. with 44% of records.

Which FDA product codes apply?

KNW (Instrument, Biopsy), KNW (INSTRUMENT, BIOPSY), GAA (Needle, Aspiration And Injection, Disposable), DYB (Introducer, Catheter)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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