# K000386: Polygram 98 Anorectal Function Testing Application, Model 9043S0111

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: May 5, 2000 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041244: Polygram Net Biofeedback Application (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K000386
Methodology: https://510kreport.com/methodology