FDA product code OKS: Lacrimal Stents And Intubation Sets
OKS is the FDA product code for lacrimal stents and intubation sets. It is a Unclassified device, reviewed by the Ophthalmic panel. FDA has cleared 31 510(k) submissions under OKS, from 19 different applicants. The average 510(k) review took 174 days (median 166).
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.
Classification
| Field | Value |
|---|---|
| Device name | Lacrimal Stents And Intubation Sets |
| Device class | Unclassified |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OKS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 81 |
| 2020 | 1 | 186 |
| 2021 | 1 | 246 |
Compare with all 510(k) review times · Search every OKS clearance
Top OKS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fci Ophthalmics, Inc. | 4 | 2006-08-07 |
| Fci Sas (France Chirurgie Instrumentation) | 3 | 2013-12-04 |
| G.W.B. Intl., Ltd. | 3 | 1996-03-06 |
| Fci (France Chirurgie Instrumentation) Sas | 2 | 2021-03-11 |
| Armadillo Biomedical, LLC | 2 | 2015-01-12 |
14 more applicants have OKS clearances. See the full list in Caduvo.
Most recent OKS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201892 | Fci (France Chirurgie Instrumentation) Sas | Ritleng®+ and Ritleng®+ PVP | 2021-03-11 | 246 |
| K201606 | Fci (France Chirurgie Instrumentation) Sas | LacriJet® | 2020-12-18 | 186 |
| K170247 | Kaneka Pharma America, LLC | Lacriflow CL | 2017-04-18 | 81 |
| K161373 | Fci (France Chirurgie Instrumentation) | Nunchaku | 2016-11-03 | 170 |
| K160710 | Anodyne | Oasis Lacrimal Intubation Set | 2016-05-13 | 59 |
Recalls for OKS devices
openFDA lists no recalls for product code OKS.
Frequently asked questions
What is FDA product code OKS?
OKS is the FDA product code for lacrimal stents and intubation sets. It is a Unclassified device, reviewed by the Ophthalmic panel.
What device class is OKS?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code OKS?
Across 31 cleared submissions the average was 174 days from receipt to decision (median 166).
Which companies have the most OKS clearances?
Fci Ophthalmics, Inc. (4); Fci Sas (France Chirurgie Instrumentation) (3); G.W.B. Intl., Ltd. (3); Fci (France Chirurgie Instrumentation) Sas (2); Armadillo Biomedical, LLC (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OKS
- Run a recall and safety report across every OKS manufacturer
- Watch product code OKS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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