DCS Lacrimal Stent
FDA 510(k) K113316 · Dcs Surgical, Inc.
510(k) numberK113316
Submission
- Device name
- DCS Lacrimal Stent
- Applicant
- Dcs Surgical, Inc.
Boulder, CO, US - Received
- November 9, 2011
- Decision date
- November 8, 2012
- 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…
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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 |
| K123831 | Ophtacath KitOKS · Traditional | France Chirurgae Instrumentation | 07/29/2013SE |
| K120886 | LacrifastOKS · Traditional | Hiroyasu Higuchi | 12/17/2012SE |
Questions and answers
When was DCS Lacrimal Stent cleared by the FDA?
DCS Lacrimal Stent (K113316) received a 510(k) decision of Substantially Equivalent on November 8, 2012, 365 days after the submission was received.
What is the product code of K113316?
The FDA product code is OKS – Lacrimal Stents And Intubation Sets, a Unclassified device.