An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue
| Company | Devices | Share |
|---|---|---|
| Histo S.A. | 88 | 62% |
| Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi | 26 | 18% |
| Bard Peripheral Vascular, Inc. | 25 | 18% |
| Medax Srl Unipersonale | 2 | 1% |
Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| DWO | Needle, Biopsy, Cardiovascular | 88 |
| FCG | Biopsy needle | 46 |
| KNW | Instrument, Biopsy | 44 |
| KNW | INSTRUMENT, BIOPSY | 29 |
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 12 |
Use these as the dimensions to specify in a tender line.
141 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Side-notch biopsy gun needle", from 4 companies. The largest labeler is Histo S.A. with 62% of records.
DWO (Needle, Biopsy, Cardiovascular), FCG (Biopsy needle), KNW (Instrument, Biopsy), KNW (INSTRUMENT, BIOPSY)
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.