Consulting Wallah › Device Explorer › Procedure kits & trays › Ultrasound aspiration biopsy procedure kit
Device Explorer · FDA GUDID · GMDN 10403

Ultrasound aspiration biopsy procedure kit

A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.

US‑registered devices75in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Micro-Tech (Nanjing) Co., Ltd.3344%
Cook Ireland Ltd1824%
Medi-Globe Gmbh1520%
Praxis Medical Llc79%
Limaca Medical Ltd.11%
Cook Incorporated11%

Top labelers

CompanyDevicesShare
Micro-Tech (Nanjing) Co., Ltd.3344%
Cook Ireland Ltd1824%
Medi-Globe Gmbh1520%
Praxis Medical Llc79%
Limaca Medical Ltd.11%
Cook Incorporated11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Precision GI 20GA Motorized EUS Biopsy DeviceAreus(TM) Adapt Endoscopic Ultrasound AspirationTrident(TM) Adapt Endoscopic Ultrasound Biopsy NTrident(TM) Endoscopic Ultrasound Biopsy Needle Areus(TM) Endoscopic Ultrasound Aspiration NeedlClearViewSonoTip Pro ControlSonoTip II EBUSIon Pouch BVEndoCoreOlympus Pouch FROlympus Pouch BVMonarch Pouch FRMonarch Pouch BVIon Pouch FREchoTip ClearCore

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

FDA product codes

CodeNameDevices
FCGBiopsy Needle33
ODGEndoscopic Ultrasound System, Gastroenterology-Urology20
FCGBiopsy needle20
KTIBronchoscope Accessory7
ODGEndoscopic ultrasound system, gastroenterology-urology2

GMDN & GCC registration

  • GMDN code 10403 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 48

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

No closely related category with 50+ devices.

How many ultrasound aspiration biopsy procedure kit products are registered in the US?

75 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasound aspiration biopsy procedure kit", from 6 companies. The largest labeler is Micro-Tech (Nanjing) Co., Ltd. with 44% of records.

Which FDA product codes apply?

FCG (Biopsy Needle), ODG (Endoscopic Ultrasound System, Gastroenterology-Urology), FCG (Biopsy needle), KTI (Bronchoscope Accessory)

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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