Consulting Wallah › Device Explorer › Syringes, needles & infusion › Side-notch biopsy gun handpiece/needle
Device Explorer · FDA GUDID · GMDN 58990

Side-notch biopsy gun handpiece/needle

A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consis

US‑registered devices1,164in commercial distribution
Companies17labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Zhejiang Curaway Medical Technology Co., Ltd.64856%
Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi18216%
Bard Peripheral Vascular, Inc.918%
Möller Medical Gmbh555%
H.S. Hospital Service Spa393%
Devicor Medical Products, Inc.292%
Hologic, Inc.282%
Suzhou Leapmed Healthcare Corporation262%

Top labelers

CompanyDevicesShare
Zhejiang Curaway Medical Technology Co., Ltd.64856%
Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi18216%
Bard Peripheral Vascular, Inc.918%
Möller Medical Gmbh555%
H.S. Hospital Service Spa393%
Devicor Medical Products, Inc.292%
Hologic, Inc.282%
Suzhou Leapmed Healthcare Corporation262%
Inrad252%
Apriomed Ab121%
Myco Medical Supplies Inc.71%
Medax Srl Unipersonale61%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AprioCore plusCarbonMedLeapmedCurawayEviva Needle GuideCelero IntroducerATEC Needle GuideDisposable Automatic Biopsy GunDisposable Semi-Automatic Biopsy GunPrimoCutInvivoMammotome eliteMammotome revolveMammotome Revolve EXMammotome RevolveMammotome

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

FDA product codes

CodeNameDevices
KNWInstrument, Biopsy1,091
KNWINSTRUMENT, BIOPSY142
FCGBiopsy Needle50
MJGDEVICE, PERCUTANEOUS, BIOPSY9
MJGDevice, percutaneous, biopsy4

GMDN & GCC registration

  • GMDN code 58990 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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) · 309Length (Centimeter) · 207Length (Millimeter) · 70

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

How many side-notch biopsy gun handpiece/needle products are registered in the US?

1,164 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Side-notch biopsy gun handpiece/needle", from 17 companies. The largest labeler is Zhejiang Curaway Medical Technology Co., Ltd. with 56% of records.

Which FDA product codes apply?

KNW (Instrument, Biopsy), KNW (INSTRUMENT, BIOPSY), FCG (Biopsy Needle), MJG (DEVICE, PERCUTANEOUS, BIOPSY)

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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