K012108 is an FDA 510(k) clearance for the MEDPOR COATED TEAR DRAIN. This device is classified as a Lacrimal Stents And Intubation Sets.
Submitted by Porex Surgical, Inc. (Newnan, US). The FDA issued a Cleared decision on December 19, 2001, 166 days after receiving the submission on July 6, 2001.
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 | K012108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2001 |
| Decision Date | December 19, 2001 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| 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. |