Pure-Vu
The Pure-Vu loading and unloading fixtures assist staff in attaching and removing the system's colonoscope add-on. The loading fixture helps mount the add-on to a standard colonoscope,…
The Pure-Vu loading and unloading fixtures assist staff in attaching and removing the system’s colonoscope add-on. The loading fixture helps mount the add-on to a standard colonoscope, while the unloading fixture helps remove it after use. They are handling accessories rather than the cleaning workstation.
The add-on is the component used during colonoscopy to irrigate and evacuate a poorly prepared colon. A workstation controls liquid-and-air irrigation and removal of fecal matter and fluid. A cartridge connects the add-on, workstation and fluid supply.
Listed Item
(1) Loading fixture & (1) Unloading fixture with sealing plugs
Staff and Procedure Context
The system is intended for trained medical personnel in hospitals, clinics or doctors’ offices. Its loading fixtures support setup of the add-on and are distinct from pumps, regulators and foot controls that operate the cleansing cycle. The record concerns the loading and unloading fixture set.
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 | Motus GI Inc, United States |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K160015 |
| Record published | 2017-01-03 |
| Record revised | 2024-06-19 (version 4) |
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, serial number |
| Storage | Handling environment atmospheric pressure 0 to 81 KiloPascal; Handling environment humidity 10 to 80 % RH; Handling environment temperature 10 to 30 °C; Storage environment humidity 10 to 80 % RH; Storage environment temperature -10 to 60 °C |
| Packaging | Large box of 5, 5 small boxes in 1 of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PV-WS-001 | In distribution | |
| PV-OSK-001 | In distribution | |
| PV-WSC-001 | In distribution | |
| PV-OS-001 | In distribution | |
| PV-WSCK-001 | In distribution | |
| PV-SLM-001 | In distribution | |
| PV-LF-001 | In distribution | |
| PV-SLMK-001 | In distribution | |
| PV-LUFK-001 | In distribution | |
| PV-UF-001 | In distribution |
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 |
|---|---|
| K232922 | 2023-10-20 |
| K220007 | 2022-02-10 |
| K210981 | 2021-04-29 |
| K191220 | 2019-06-06 |
| K181437 | 2018-06-21 |
| K173392 | 2017-12-12 |
| K160015 | 2016-09-22 |
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.