K023758 is an FDA 510(k) clearance for the BECKER TRANSNASAL LACRIMAL (INTUBATION SETS). This device is classified as a Lacrimal Stents And Intubation Sets.
Submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on September 17, 2003, 313 days after receiving the submission on November 8, 2002.
This device falls under the Ophthalmic FDA review panel. 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..
| 510(k) Number | K023758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2002 |
| Decision Date | September 17, 2003 |
| Days to Decision | 313 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | OKS — Lacrimal Stents And Intubation Sets |
| Device Class | — |
| Definition | 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. |