# K121142: Crawford Biocanaliculus Intubation

- Pathway: 510(k) (Traditional)
- Applicant: Fci Sas (France Chirurgie Instrumentation)
- Decided: Aug 9, 2012 after 115 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 K991238 (1999). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991238: Fci Crawford Probe Intubation Sets, Fci Ophthalmics, Inc. (1999) Summary page 1.
- K061404: Mono-Crawford Naso-Lacrimal Intubation Device, Fci Ophthalmics, Inc. (2006) Summary page 1.

## Most influential descendants
- K161373: Nunchaku (2016), 0 descendants of its own
- K160710: Oasis Lacrimal Intubation Set (2016), 0 descendants of its own

## Indications for use
The Crawford Bicanaticulus Intubation stents are intended for use for nasolacrimat intubation in patients 12 months of age and older. Indications for nasolacrimal intubation performed with the Crawford Bicanaliculus Intubation are: Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations) During dacryocystorhinostomy Congenital lacrimal duct obstruction

Source page: https://510kreport.com/device/K121142
Methodology: https://510kreport.com/methodology