Solar GI LGI H20, Trolley System
Catalogue number G3-6, listed by Medical Measurement Systems B.V., Netherlands, under System, Gastrointestinal Motility (Electrical). 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
5510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Medical Technologies (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
Record
| Listed by | Medical Measurement Systems B.V., Netherlands |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| Establishment | Exporter |
| Record published | 2016-09-23 |
| Record revised | 2026-01-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G3-6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mui Scientific | H&A Mui Enterprises, Inc. | 771 |
| UniTip High Resolution Catheter | Unisensor AG | 183 |
| UniTip Catheter | Unisensor AG | 100 |
| ManoScan | Given Imaging Ltd. | 60 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 27 |
| inSIGHT Ultima | Diversatek Healthcare Inc | 19 |
| Endoflip | Covidien LP | 17 |
| Sitzmarks Radiopaque Markers | Konsyl Pharmaceuticals, Inc. | 14 |
| Zvu® | Diversatek Healthcare Inc | 11 |
| Distender II Barostat | G & J Electronics, Inc. | 9 |
| PriZm | Diversatek Healthcare Inc | 8 |
| ManoView | Given Imaging Ltd. | 6 |
Showing 12 of 107. All products under System, Gastrointestinal Motility (Electrical)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121014 | 2012-08-01 |
| K071094 | 2007-08-13 |
| K060166 | 2006-04-21 |
| K052338 | 2005-12-15 |
| K031084 | 2004-03-19 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Laborie Medical Technologies Corp. | UDI-DI | 2026-05-21 | Class II | Device Design | Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system’s internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulat | 372 units |
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.