Pathfinder® Endoscope Overtube
Pathfinder Endoscope Overtube is a sleeve used around an endoscope during adult gastrointestinal procedures. It can change from flexible to rigid while retaining its current shape,…
Pathfinder Endoscope Overtube is a sleeve used around an endoscope during adult gastrointestinal procedures. It can change from flexible to rigid while retaining its current shape, providing a passage for advancing, withdrawing or exchanging the endoscope.
A rotator on the handle controls a sealed internal space. Venting this space leaves the overtube flexible; connecting it to vacuum makes the overtube rigid. The vacuum acts within the device’s contained volume.
Navigation and Setup
In its flexible state, the overtube can move with the endoscope through the gastrointestinal tract. Rigidization preserves the selected shape while the endoscope moves within it. Different lengths and internal diameters accommodate compatible endoscopes and procedures. Pathfinder is supplied ethylene oxide sterilized and discarded after use.
Who Else Makes It
Concentrated in Guangdong (10), Shanghai (4), Zhejiang (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Seplou (Zhuhai) Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Zhejiang Yigao Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Eternal (Shanghai) Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
Showing 12 of 19. All 19 manufacturers in China registered for Endoscopic Access Overtube, Gastroenterology-Urology
Record
| Listed by | Neptune Medical, Inc, United States |
|---|---|
| FDA product code | FED |
| Device type | Endoscopic Access Overtube, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K211301 |
| Record published | 2021-06-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 65 to 145 cm; outer diameter 13.5 to 18.5 mm; catheter working length 55 to 135 cm; shaft length 55 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GI 065160-2 | Length 65 cm | In distribution |
| GI 085160-2 | Length 85 cm | In distribution |
| GI 065140-2 | Length 65 cm | In distribution |
| GI 145110-2 | Length 145 cm | In distribution |
| GI 085110-2 | Length 85 cm | In distribution |
| GI 110160-2 | Length 110 cm | In distribution |
| GI 110140-2 | Length 110 cm | In distribution |
| GI 065110-2 | Length 65 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ClearPetra | Well Lead Medical Co., Ltd. | 175 |
| CoralWell | Macrolux Medical Technology Co., Ltd. | 56 |
| Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 35 |
| Single-use Ureteral Access Sheath | Shenzhen Hugemed Medical Technical Development Co., Ltd. | 25 |
| Flexor | Cook Incorporated | 25 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 24 |
| Flexor Parallel | Cook Incorporated | 21 |
| Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 20 |
| Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 18 |
| Guardus | Us Endoscopy | 16 |
| Porges Coloplast | Coloplast A/S | 14 |
| Forté® AXP Access Sheath | Applied Medical Resources Corp. | 13 |
Showing 12 of 66. All products under Endoscopic Access Overtube, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240853 | 2024-06-27 |
| K230801 | 2023-07-28 |
| K211301 | 2021-05-28 |
| K191415 | 2019-08-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.