# K980980: Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50

- Pathway: 510(k) (Traditional)
- Applicant: Konigsberg Instruments, Inc.
- Decided: Jun 15, 1998 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Koni’gsberg Instruments’ Motility Probe is manufactured for use in the evaluation and diagnosis of gastrointestinal dysfunction related to muscle tonus and the coordination of contractions between muscle groups. The Motility Probe provides several types of information which may be used in these diagnoses. Primary among these is pressure information at many of the sensor sites. Secondary to the pressure information is the ability of the probe to measure pH in the stomach and esophagus. This can reveal the presence of gastric reflux from the stomach into the esophagus.

Source page: https://510kreport.com/device/K980980
Methodology: https://510kreport.com/methodology