# K190977: Navina Smart System, Navina Classic System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Nov 22, 2019 after 221 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: 8 generations back to K813526 (1982). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170487: Navina Classic System, Dentsply Sirona (2017) Summary page 4.
- K140310: Peristeen Anal Irrigation System, Coloplast A/S (2015) Summary page 4.

## Indications for use
The Navina Systems are indicated for use for children (2 - <12 years old), adolescents (12 - <18 years old), and transitional adolescents (18 - <21 years old) patients with neurogenic bowel dysfunction, congenital disorders such as Hirschsprung disease or anorectal malformations, fecal incontinence or chronic constipation where less invasive therapies are not successful, as well as, for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. Use for pediatric patients is to be performed under the supervision of a trained healthcare professional or adult caregiver. By instilling water up into the lower part of the colon, the Navina Systems promote evacuation of the contents of the colon and rectum. The Navina Small Rectal Balloon catheter is limited to use for adolescent (12 - <18 years old) and transitional adolescent (18 - < 21 years old) patients and adults. The Navina Regular Rectal Balloon catheter is limited to use for adults. The Navina Cone catheter is limited to use for children (2 - < 12 years old), adolescent (12 - <18 years old) and transitional adolescent (18 - < 21 years old) patients and adults.

Source page: https://510kreport.com/device/K190977
Methodology: https://510kreport.com/methodology