510(k) K130375
K130375 is an FDA 510(k) premarket notification submitted by Fci Sas (France Chirurgie Instrumentation) for the device "SELF-RETAINING BICANALICULUS INTUBATON SET II". The FDA issued a decision of Substantially Equivalent on December 4, 2013. The device falls under product code OKS (Lacrimal Stents And Intubation Sets), a Class U device. Fci Sas (France Chirurgie Instrumentation) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2013
- Date Received
- February 14, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lacrimal Stents And Intubation Sets
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type
Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.