A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered
| Company | Devices | Share |
|---|---|---|
| Cook Incorporated | 252 | 40% |
| Terumo Cardiovascular Systems Corporation | 153 | 24% |
| Boston Scientific Corporation | 54 | 9% |
| Jiangsu Grit Medical Technology Co., Ltd. | 32 | 5% |
| Coloplast A/S | 26 | 4% |
| Shenzhen Trious Medical Technology Co., Ltd | 24 | 4% |
| Seplou (Zhuhai) Co.,Ltd. | 23 | 4% |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | 23 | 4% |
| Sintea Plustek Srl | 16 | 3% |
| Olympus Winter & Ibe Gmbh | 5 | 1% |
| Allwin Medical Devices, Inc. | 4 | 1% |
| Qtec Ce-Med Gmbh | 3 | 0% |
Company = labeler of record on GUDID. 20 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 |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 180 |
| KOE | DILATOR, URETHRAL | 151 |
| FED | endoscopic access overtube, gastroenterology-urology | 81 |
| EZN | DILATOR, CATHETER, URETERAL | 77 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 48 |
| KNQ | Dilator, Esophageal | 32 |
Use these as the dimensions to specify in a tender line.
630 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic-access dilator, single-use", from 20 companies. The largest labeler is Cook Incorporated with 40% of records.
GCJ (Laparoscope, General & Plastic Surgery), KOE (DILATOR, URETHRAL), FED (endoscopic access overtube, gastroenterology-urology), EZN (DILATOR, CATHETER, URETERAL)
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.