# K201892: Ritleng®+ and Ritleng®+ PVP

- Pathway: 510(k) (Traditional)
- Applicant: Fci (France Chirurgie Instrumentation) Sas
- Decided: Mar 11, 2021 after 246 days
- Product code: OKS (Lacrimal Stents And Intubation Sets)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955671 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955671: Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.), G.W.B. Intl., Ltd. (1996) Summary page 4.

## Indications for use
The RITLENG®+ products are indicated in the treatment of epiphora in patients of 12 months and older in cases of: - Canalicular pathologies (stenoses, obstructions, lacerations), - Congenital duct obstruction (Hasner valve stenosis), - Dacryocystorhinostomy (conventional or laser).

Source page: https://510kreport.com/device/K201892
Methodology: https://510kreport.com/methodology