Sitzmarks Radiopaque Markers
14 catalogue numbers from Combo Pak, listed by Konsyl Pharmaceuticals, Inc., United States, under System, Gastrointestinal Motility (Electrical). 1 manufacturer in China is registered for this product code.
1manufacturer
14catalogue numbers in this listing
1510(k) clearance
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 | Konsyl Pharmaceuticals, Inc., United States |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K881609 |
| Record published | 2018-06-22 |
| Record revised | 2026-04-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Combo Pak | 10 | In distribution | |
| Tri-Chamber | 10 | In distribution | |
| Combo Pak | In distribution | ||
| Double D | 10 | In distribution | |
| Double D | 10 | In distribution | |
| Round Hollow | 10 | In distribution | |
| Double D | In distribution | ||
| Round Hollow | In distribution | ||
| Double D | 10 | In distribution | |
| Tri-Chamber | In distribution | ||
| Round Hollow | 10 | In distribution | |
| Tri-Chamber | 10 | In distribution | |
| Tri-Chamber | 10 | In distribution | |
| Round Hollow | 10 | 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 |
| Zvu® | Diversatek Healthcare Inc | 11 |
| Distender II Barostat | G & J Electronics, Inc. | 9 |
| PriZm | Diversatek Healthcare Inc | 8 |
| ManoView | Given Imaging Ltd. | 6 |
| System, Gastrointestinal Motility (Electrical) | Given Imaging Ltd. | 6 |
Showing 12 of 107. All products under System, Gastrointestinal Motility (Electrical)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181750 | 2018-11-15 |
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.