OKS · Lacrimal Stents And Intubation Sets
· Class U
Overview
| Product Code | OKS |
|---|---|
| Device Name | Lacrimal Stents And Intubation Sets |
| Device Class | Class U |
| Review Panel | |
| Implant | Yes |
Identification
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.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201892 | Ritleng®+ and Ritleng®+ PVP | Fci (France Chirurgie Instrumentation) Sas | Mar 11, 2021 | SESE |
| K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | Dec 18, 2020 | SESE |
| K170247 | Lacriflow CL | Kaneka Pharma America, LLC | Apr 18, 2017 | SESE |
| K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | Nov 3, 2016 | SESE |
| K160710 | Oasis Lacrimal Intubation Set | Anodyne | May 13, 2016 | SESK |
| K142914 | DacryoCATH | Armadillo Biomedical, LLC | Jan 12, 2015 | SESE |
| K140290 | STOPLOSS JONES TUBE | Ljt Surgical, Ltd. | Dec 2, 2014 | SESE |
| K130375 | SELF-RETAINING BICANALICULUS INTUBATON SET II | Fci Sas (France Chirurgie Instrumentation) | Dec 4, 2013 | SESE |
| K123831 | OPHTACATH KIT | France Chirurgae Instrumentation | Jul 29, 2013 | SESE |
| K120886 | LACRIFAST | Hiroyasu Higuchi | Dec 17, 2012 | SESE |
| K113316 | DCS LACRIMAL STENT | Dcs Surgical, Inc. | Nov 8, 2012 | SESE |
| K113867 | LACRICATH LACRIMAL DUCT CATHETER | Quest Medical, Inc. | Oct 19, 2012 | SESE |
| K113508 | DACRYOCATH | Armadillo Biomedical, LLC | Aug 31, 2012 | SESE |
| K121142 | CRAWFORD BIOCANALICULUS INTUBATION | Fci Sas (France Chirurgie Instrumentation) | Aug 9, 2012 | SESE |
| K113536 | MASTERKA 40 MASTERKA 35 MASTERKA 30 | Fci Sas (France Chirurgie Instrumentation) | Aug 3, 2012 | SESE |
| K113118 | STENTUBE LACRIMAL INTUBATION SET | Quest Medical, Inc. | Jul 31, 2012 | SESE |
| K061404 | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | Fci Ophthalmics, Inc. | Aug 7, 2006 | SESE |
| K041869 | SELF RETAINING BICANALICULUS INTUBATION SET | Fci Ophthalmics, Inc. | Nov 18, 2004 | SESE |
| K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | Fci Ophthalmics, Inc. | Sep 17, 2003 | SESE |
| K030353 | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS | Eagle Vision, Inc. | Apr 25, 2003 | SESE |
Top Applicants
- Fci Ophthalmics, Inc. — 4 clearances
- Fci Sas (France Chirurgie Instrumentation) — 3 clearances
- G.W.B. Intl., Ltd. — 3 clearances
- Armadillo Biomedical, LLC — 2 clearances
- Atrion Medical Products, Inc. — 2 clearances
