# K161373: Nunchaku

- Pathway: 510(k) (Traditional)
- Applicant: Fci (France Chirurgie Instrumentation)
- Decided: Nov 3, 2016 after 170 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: 2 generations back to K991238 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121142: Crawford Biocanaliculus Intubation, Fci Sas (France Chirurgie Instrumentation) (2012) Summary page 4.
- K120886: Lacrifast, Hiroyasu Higuchi (2012) Summary page 4.
- K130375: Self-Retaining Bicanaliculus Intubaton Set II, Fci Sas (France Chirurgie Instrumentation) (2013) Summary page 4.

## Indications for use
The Nunchaku stents are intended for use for nasolacrimal intubation in patients 12 months and older. Indications for nasolacrimal intubation performed with the Nunchaku are: - Canalicular pathologies (e.g., congenital or acquired stenosis, laceration) - During dacryocystorhinostomy - Congenital lacrimal duct obstruction

Source page: https://510kreport.com/device/K161373
Methodology: https://510kreport.com/methodology