GripTract-GI Endoscopic Tissue Manipulator
GripTract-GI is an endoscope accessory for tissue manipulation and visualization in the large intestine. It helps position the distal endoscope tip relative to the mucosal surface while…
GripTract-GI is an endoscope accessory for tissue manipulation and visualization in the large intestine. It helps position the distal endoscope tip relative to the mucosal surface while supporting endoscopic diagnosis and treatment.
A handpiece attaches below the endoscope working channel, and a soft end cap with two movable fingers fits on the distal tip. Separate knobs rotate and extend or retract each finger independently of scope movement and other tools.
Listed Item
GripTract-GI Model GT-CM170 is a single-use, non-sterile, endoscope accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. GripTract Model GT-CM170 is indicated for use in the large intestine with any standard endoscope with a distal tip outer diameter of 11.5 → 12.0 mm and a working length of 168 -170 cm.
Scope Fit
Lower GI models accommodate specified endoscope tip diameters and working lengths. The CL models fit 12.8 to 13.3 mm tips, while CM models fit 11.5 to 12.0 mm tips, with short and long working length options. The accessories are disposable and nonsterile.
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Create Medical Products Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 2 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Actuated Medical, Inc., United States |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K242325 |
| Record published | 2025-01-16 |
| Record revised | 2025-04-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 5, carton of 5 |
| Distribution end date | 2025-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GT-CM170 | In distribution | |
| GT-CM130 | In distribution | |
| GT-CL170 | In distribution | |
| GT-CL130 | In distribution | |
| GT-101 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fuse | Endochoice, Inc. | 52 |
| Colonoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 51 |
| Fujifilm | Fujifilm Corporation | 40 |
| Pentax | Hoya Corporation | 37 |
| Video Colonoscope | Pentax of America, Inc. | 25 |
| G-EYE Colonoscope | Smart Medical Systems Ltd. | 24 |
| Medisono | Medisono, LLC | 18 |
| Evis Exera lll Colonovideoscope | Olympus Medical Systems Corp. | 16 |
| Endoch | Endoch Inc | 14 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonoscope And Accessories, Flexible/Rigid | Hangzhou AGS MedTech Co., Ltd. | 10 |
Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242325 | 2024-10-04 |
| K231254 | 2023-11-03 |
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.