Ophtacath Kit
FDA 510(k) K123831 · France Chirurgae Instrumentation
510(k) numberK123831
Submission
- Device name
- Ophtacath Kit
- Applicant
- France Chirurgae Instrumentation
Cincinnati, OH, US - Received
- December 12, 2012
- Decision date
- July 29, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OKS – Lacrimal Stents And Intubation Sets
- Device class
- Unclassified
- Implant
- Yes
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…
Other 510(k)s with product code OKS
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|---|---|---|---|
| K201892 | Ritleng®+ and Ritleng®+ PVPOKS · Traditional | Fci (France Chirurgie Instrumentation) Sas | 03/11/2021SE |
| K201606 | LacriJet®OKS · Traditional | Fci (France Chirurgie Instrumentation) Sas | 12/18/2020SE |
| K170247 | Lacriflow CLOKS · Special | Kaneka Pharma America, LLC | 04/18/2017SE |
| K161373 | NunchakuOKS · Traditional | Fci (France Chirurgie Instrumentation) | 11/03/2016SE |
| K160710 | Oasis Lacrimal Intubation SetOKS · Traditional | Anodyne | 05/13/2016SESK |
| K142914 | DacryoCATHOKS · Special | Armadillo Biomedical, LLC | 01/12/2015SE |
| K140290 | Stoploss Jones TubeOKS · Traditional | Ljt Surgical, Ltd. | 12/02/2014SE |
| K130375 | Self-Retaining Bicanaliculus Intubaton Set IIOKS · Traditional | Fci Sas (France Chirurgie Instrumentation) | 12/04/2013SE |
| K120886 | LacrifastOKS · Traditional | Hiroyasu Higuchi | 12/17/2012SE |
| K113316 | DCS Lacrimal StentOKS · Traditional | Dcs Surgical, Inc. | 11/08/2012SE |
Questions and answers
When was Ophtacath Kit cleared by the FDA?
Ophtacath Kit (K123831) received a 510(k) decision of Substantially Equivalent on July 29, 2013, 229 days after the submission was received.
What is the product code of K123831?
The FDA product code is OKS – Lacrimal Stents And Intubation Sets, a Unclassified device.