UniTip Catheter
100 catalogue numbers from K6391-00-1114, listed by Unisensor AG, United States, under System, Gastrointestinal Motility (Electrical). 1 manufacturer in China is registered for this product code.
1manufacturer
100catalogue numbers in this listing
2510(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 | Unisensor AG, United States |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| 510(k) | K003580 |
| Record published | 2016-09-19 |
| Record revised | 2022-08-05 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Sizes | Catheter gauge 3 to 14 Fr |
| Distribution end date | 2018-09-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K6391-00-1114 | Catheter Gauge 6 Fr | In distribution |
| K8372-00-1133 | Catheter Gauge 8 Fr | In distribution |
| K10504-L5-0304-D | Catheter Gauge 10 Fr | In distribution |
| K10581-E-0748-D | Catheter Gauge 10 Fr | In distribution |
| K8404-L4-1526-D | Catheter Gauge 8 Fr | In distribution |
| K4100-00-9962-D | Catheter Gauge 4 Fr | In distribution |
| K6425-00-0657 | Catheter Gauge 6 Fr | In distribution |
| K5204-L3-1322-D | Catheter Gauge 5 Fr | In distribution |
| K12400-00-1317-D | Catheter Gauge 12 Fr | In distribution |
| K5126-00-1618-D | Catheter Gauge 5 Fr | In distribution |
| K5372-L3-0943 | Catheter Gauge 5 Fr | In distribution |
| K12304-00-1742-D | Catheter Gauge 12 Fr | In distribution |
| K8604-00-1516-D | Catheter Gauge 8 Fr | In distribution |
| K5304-L3-1279-D | Catheter Gauge 5 Fr | In distribution |
| K5126-00-9857-D | Catheter Gauge 5 Fr | In distribution |
| K8400-00-1300-D | Catheter Gauge 8 Fr | In distribution |
| K10400-L5-0421-D | Catheter Gauge 10 Fr | In distribution |
| K3104-00-1426-D | Catheter Gauge 3 Fr | In distribution |
| K4491-00-0938 | Catheter Gauge 4 Fr | In distribution |
| K4291-00-0581 | Catheter Gauge 4 Fr | In distribution |
| K8404-L4-0780-D | Catheter Gauge 8 Fr | In distribution |
| K14800-L5-0346-D | Catheter Gauge 14 Fr | In distribution |
| K8100-00-1423-D | Catheter Gauge 8 Fr | In distribution |
| K8372-00-1338 | Catheter Gauge 8 Fr | In distribution |
| K5304-00-0437-D | Catheter Gauge 5 Fr | In distribution |
| K6604-00-2011-D | Catheter Gauge 6 Fr | In distribution |
| K8404-00-9833-D | Catheter Gauge 8 Fr | In distribution |
| K8204-00-1517-D | Catheter Gauge 8 Fr | In distribution |
| K8404-00-0222-D | Catheter Gauge 8 Fr | In distribution |
| K10404-L5-1357-D | Catheter Gauge 10 Fr | In distribution |
| K14204-L-1007-D | Catheter Gauge 14 Fr | In distribution |
| K5374-L3-0479-D | Catheter Gauge 5 Fr | In distribution |
| K10400-L4-0427-D | Catheter Gauge 10 Fr | In distribution |
| K8204-00-0071-D | Catheter Gauge 8 Fr | In distribution |
| K14404-L5-0602-D | Catheter Gauge 14 Fr | In distribution |
| K8104-00-0129-D | Catheter Gauge 8 Fr | In distribution |
| K8104-00-1144-D | Catheter Gauge 8 Fr | In distribution |
| K121004-00-1648-D | Catheter Gauge 12 Fr | In distribution |
| K10604-L5-13102-D | Catheter Gauge 10 Fr | In distribution |
| K8400-00-0880-D | Catheter Gauge 8 Fr | In distribution |
| K10600-L5-0238-D | Catheter Gauge 10 Fr | In distribution |
| K5200-L3-0861-D | Catheter Gauge 5 Fr | In distribution |
| K8400-00-0168-D | Catheter Gauge 8 Fr | In distribution |
| K14481-L5-0627-D | Catheter Gauge 14 Fr | In distribution |
| K12426-00-1174-D | Catheter Gauge 12 Fr | In distribution |
| K8871-L4-1638 | Catheter Gauge 8 Fr | In distribution |
| K12600-L5-1481-D | Catheter Gauge 12 Fr | In distribution |
| K12581-00-1146-D | Catheter Gauge 12 Fr | In distribution |
| K8404-00-0002-D | Catheter Gauge 8 Fr | In distribution |
| K8804-00-1823-D | Catheter Gauge 8 Fr | In distribution |
| K8404-00-1903-D | Catheter Gauge 8 Fr | In distribution |
| K6100-00-0186-D | Catheter Gauge 6 Fr | In distribution |
| K12172-00-2009 | Catheter Gauge 12 Fr | In distribution |
| K14172-00-2010 | Catheter Gauge 14 Fr | In distribution |
| K12944-L5-1034 | Catheter Gauge 12 Fr | In distribution |
| K8474-00-0370-D | Catheter Gauge 8 Fr | In distribution |
| K6100-00-0171-D | Catheter Gauge 6 Fr | In distribution |
| K104A2-00-2006 | Catheter Gauge 10 Fr | In distribution |
| K8833-00-1012 | Catheter Gauge 8 Fr | In distribution |
| K10604-00-1584-D | Catheter Gauge 10 Fr | In distribution |
| K5273-L3-0496-D | Catheter Gauge 5 Fr | In distribution |
| K8104-00-1741-D | Catheter Gauge 8 Fr | In distribution |
| K8733-00-10102 | Catheter Gauge 8 Fr | In distribution |
| K8881-L4-0915-D | Catheter Gauge 8 Fr | In distribution |
| K8374-L4-0750-D | Catheter Gauge 8 Fr | In distribution |
| K8868-L4-12115 | Catheter Gauge 8 Fr | In distribution |
| K8400-00-0608-D | Catheter Gauge 8 Fr | In distribution |
| K83A9-E-1477-D | Catheter Gauge 8 Fr | In distribution |
| K8871-L4-1639 | Catheter Gauge 8 Fr | In distribution |
| K6404-00-1345-D | Catheter Gauge 6 Fr | In distribution |
| K8304-00-0075-D | Catheter Gauge 8 Fr | In distribution |
| K10304-L5-1016-D | Catheter Gauge 10 Fr | In distribution |
| K12426-00-1650-D | Catheter Gauge 12 Fr | In distribution |
| K8400-00-1244-D | Catheter Gauge 8 Fr | In distribution |
| K8871-00-1637 | Catheter Gauge 8 Fr | In distribution |
| K5274-L3-0487-D | Catheter Gauge 5 Fr | In distribution |
| K8200-L4-0378-D | Catheter Gauge 8 Fr | In distribution |
| K8400-00-1587-D | Catheter Gauge 8 Fr | In distribution |
| K12172-00-1907 | Catheter Gauge 12 Fr | In distribution |
| K14172-00-1906 | Catheter Gauge 14 Fr | In distribution |
| K10904-00-0795-D | Catheter Gauge 10 Fr | In distribution |
| K8404-L4-1351-D | Catheter Gauge 8 Fr | In distribution |
| K14819-L-0814 | Catheter Gauge 14 Fr | In distribution |
| K14104-L-1277-D | Catheter Gauge 14 Fr | In distribution |
| K8472-00-1730 | Catheter Gauge 8 Fr | In distribution |
| K10400-L5-0859-D | Catheter Gauge 10 Fr | In distribution |
| K10604-L5-1060-D | Catheter Gauge 10 Fr | In distribution |
| K8104-L4-0034-D | Catheter Gauge 8 Fr | In distribution |
| K4104-00-1366-D | Catheter Gauge 4 Fr | In distribution |
| K6304-00-9931-D | Catheter Gauge 6 Fr | In distribution |
| K12504-00-1818-D | Catheter Gauge 12 Fr | In distribution |
| K8100-00-0072-D | Catheter Gauge 8 Fr | In distribution |
| K10604-L5-1808-D | Catheter Gauge 10 Fr | In distribution |
| K14400-L5-0760-D | Catheter Gauge 14 Fr | In distribution |
| K10400-00-0332-D | Catheter Gauge 10 Fr | Withdrawn |
| K10433-00-12127 | Catheter Gauge 10 Fr | Withdrawn |
| K10148-00-1455 | Catheter Gauge 10 Fr | Withdrawn |
| K10100-00-9510-D | Catheter Gauge 10 Fr | Withdrawn |
| K8404-00-0180-D | Catheter Gauge 8 Fr | Withdrawn |
| K8481-00-0476-D | Catheter Gauge 8 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mui Scientific | H&A Mui Enterprises, Inc. | 771 |
| UniTip High Resolution Catheter | Unisensor AG | 183 |
| 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 |
| 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 |
|---|---|
| K062222 | 2007-03-15 |
| K003580 | 2001-07-31 |
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.