# K130375: Self-Retaining Bicanaliculus Intubaton Set II

- Pathway: 510(k) (Traditional)
- Applicant: Fci Sas (France Chirurgie Instrumentation)
- Decided: Dec 4, 2013 after 293 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 K041869 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041869: Self Retaining Bicanaliculus Intubation Set, Fci Ophthalmics, Inc. (2004) Summary page 1.

## Most influential descendants
- K161373: Nunchaku (2016), 0 descendants of its own

## Indications for use
Bicanalicular intubation is indicated in treatments of epiphora in adults. Indications for bicanalicular intubation performed with the Self-Retaining Bicanaliculus Stent 11 are: * Punctal stenosis * Canalicular stenosis within the lacrimal drainage system

Source page: https://510kreport.com/device/K130375
Methodology: https://510kreport.com/methodology