A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropri
| Company | Devices | Share |
|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | 248 | 29% |
| Olympus Medical Systems Corp. | 166 | 20% |
| Hangzhou Ags Medtech Co., Ltd. | 90 | 11% |
| Beijing Zksk Technology Co.,Ltd | 90 | 11% |
| Covidien Lp | 47 | 6% |
| Medi-Globe Gmbh | 29 | 3% |
| Boston Scientific Corporation | 21 | 2% |
| Cook Incorporated | 16 | 2% |
| Us Endoscopy | 15 | 2% |
| Henry Schein, Inc. | 15 | 2% |
| Hobbs Medical, Inc. | 14 | 2% |
| Endo-Therapeutics, Inc. | 10 | 1% |
Company = labeler of record on GUDID. 36 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 |
|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 560 |
| FBK | endoscopic injection needle, gastroenterology-urology | 245 |
| FCG | Biopsy needle | 101 |
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 25 |
| FCG | Biopsy Needle | 15 |
| DZM | NEEDLE, DENTAL | 13 |
Use these as the dimensions to specify in a tender line.
851 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose endoscopic needle, single-use", from 36 companies. The largest labeler is Zhejiang Chuangxiang Medical Technology Co., Ltd. with 29% of records.
FBK (Endoscopic Injection Needle, Gastroenterology-Urology), FBK (endoscopic injection needle, gastroenterology-urology), FCG (Biopsy needle), GAA (NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE)
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.