Ultima
Ultima Cable for HRCA Manometry Probe (Lemo Connector)
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 | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K012232 |
| Record published | 2021-03-01 |
| Record revised | 2025-11-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H12R-7210 | In distribution | |
| H12R-7110 | 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 |
|---|---|
| K190208 | 2019-10-03 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Diversatek Healthcare Inc | 510(k) number | 2023-07-25 | Class III | Labeling Change Control | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. | 20 | |
| Diversatek Healthcare Inc | 510(k) number | 2009-02-23 | Not classified | Software change control | Software error may produce incorrect esophageal contraction readings. | 60 programs | 2012-05-07 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-06-04 | Class III | Error in labeling | Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date. | 8 |
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.