A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.
| Company | Devices | Share |
|---|---|---|
| Canyon Medical Inc. | 638 | 35% |
| Merit Medical Systems, Inc. | 386 | 21% |
| Medax Srl Unipersonale | 213 | 12% |
| Izi Medical Products, Llc | 190 | 11% |
| Sterylab Srl | 83 | 5% |
| Mermaid Medical A/S | 55 | 3% |
| Beijing Zksk Technology Co.,Ltd | 48 | 3% |
| Kitazato Corporation | 48 | 3% |
| Bioncise | 25 | 1% |
| Senorx, Inc. | 24 | 1% |
| Cook Incorporated | 20 | 1% |
| Suzhou Leapmed Healthcare Corporation | 15 | 1% |
Company = labeler of record on GUDID. 25 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 |
|---|---|---|
| KNW | Instrument, Biopsy | 1,159 |
| KNW | INSTRUMENT, BIOPSY | 323 |
| FCG | Biopsy needle | 182 |
| FCG | Biopsy Needle | 113 |
| GDF | GUIDE, NEEDLE, SURGICAL | 67 |
| DWO | Needle, Biopsy, Cardiovascular | 55 |
Use these as the dimensions to specify in a tender line.
1,799 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Soft-tissue biopsy procedure kit, non-medicated", from 25 companies. The largest labeler is Canyon Medical Inc. with 35% of records.
KNW (Instrument, Biopsy), KNW (INSTRUMENT, BIOPSY), FCG (Biopsy needle), FCG (Biopsy Needle)
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.