# K170487: Navina Classic System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Sep 11, 2017 after 206 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K813526 (1982). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140310: Peristeen Anal Irrigation System, Coloplast A/S (2015) Summary page 4.

## Most influential descendants
- K190977: Navina Smart System, Navina Classic System (2019), 0 descendants of its own

## Indications for use
The Navina Classic System is indicated for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. The Navina Classic System is intended to promote evacuation of the contents of the colon and rectum by instilling water into the lower part of the colon through a rectal catheter which incorporates an inflatable balloon.

Source page: https://510kreport.com/device/K170487
Methodology: https://510kreport.com/methodology