# K062222: Unitip High Resolution Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Unisensor AG
- Decided: Mar 15, 2007 after 225 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011472 (2001). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003580: Unitip Gastrointestinal Pressure Sensor Catheter, Unisensor AG (2001) Summary page 2.
- K031169: Motility Visualization System, Sierra Scientific Instruments, Inc. (2003) Summary page 2.

## Most influential descendants
- K190208: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (2019), 0 descendants of its own
- K102801: Phtip Disposable Isfet Catheter (2010), 0 descendants of its own

## Indications for use
The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data. The device is manufactured in the basic model variations listed below: 1. High Resolution Gastrointestinal Catheter with up to 40 pressure sensors: This model variation is intended for simple direct esophageal pressure, either at, above, or below the specific site of interest. Pressure information is provided at multiple sensor sites. Pressures may be measured continuously, at rest, or dynamically. 2. Gastrointestinal catheter, with pH sensors: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except that this model variation includes up to 7 pH sensors. PH probes are added to allow measurements of pH in the stomach and/or esophagus. 3. Gastrointestinal catheter, with sleeve: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except one or more of the pressure sensor sites will include a sleeve. The sleeve is added to broaden the pressure sensitive zone for the sensor site, and reduce positioning sensitivity. 4. Gastrointestinal catheter, with impedance rings: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes up to 14 conductive rings for impedance studies. 5. Gastrointestinal catheter, with lumen This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes a lumen.

Source page: https://510kreport.com/device/K062222
Methodology: https://510kreport.com/methodology