OKS — Lacrimal Stents And Intubation Sets Class U
FDA product code OKS covers "Lacrimal Stents And Intubation Sets", a Class U medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OKS
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Unknown
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201892 | fci (france chirurgie instrumentation) | Ritleng®+ and Ritleng®+ PVP | March 11, 2021 |
| K201606 | fci (france chirurgie instrumentation) | LacriJet® | December 18, 2020 |
| K170247 | kaneka pharma america | Lacriflow CL | April 18, 2017 |
| K161373 | fci (france chirurgie instrumentation) | Nunchaku | November 3, 2016 |
| K160710 | anodyne | Oasis Lacrimal Intubation Set | May 13, 2016 |
| K142914 | armadillo biomedical | DacryoCATH | January 12, 2015 |
| K140290 | ljt surgical | STOPLOSS JONES TUBE | December 2, 2014 |
| K130375 | fci sas (france chirurgie instrumentation) | SELF-RETAINING BICANALICULUS INTUBATON SET II | December 4, 2013 |
| K123831 | france chirurgae instrumentation | OPHTACATH KIT | July 29, 2013 |
| K120886 | hiroyasu higuchi | LACRIFAST | December 17, 2012 |
| K113316 | dcs surgical | DCS LACRIMAL STENT | November 8, 2012 |
| K113867 | quest medical | LACRICATH LACRIMAL DUCT CATHETER | October 19, 2012 |
| K113508 | armadillo biomedical | DACRYOCATH | August 31, 2012 |
| K121142 | fci sas (france chirurgie instrumentation) | CRAWFORD BIOCANALICULUS INTUBATION | August 9, 2012 |
| K113536 | fci sas (france chirurgie instrumentation) | MASTERKA 40 MASTERKA 35 MASTERKA 30 | August 3, 2012 |
| K113118 | quest medical | STENTUBE LACRIMAL INTUBATION SET | July 31, 2012 |
| K061404 | fci ophthalmics | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | August 7, 2006 |
| K041869 | fci ophthalmics | SELF RETAINING BICANALICULUS INTUBATION SET | November 18, 2004 |
| K023758 | fci ophthalmics | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | September 17, 2003 |
| K030353 | eagle vision | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS | April 25, 2003 |