Stoploss Jones Tube
FDA 510(k) K140290 · Ljt Surgical, Ltd.
510(k) numberK140290
Submission
- Device name
- Stoploss Jones Tube
- Applicant
- Ljt Surgical, Ltd.
Chevy Chase, MD, US - Received
- February 5, 2014
- Decision date
- December 2, 2014
- 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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| 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 |
| 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 |
| K113316 | DCS Lacrimal StentOKS · Traditional | Dcs Surgical, Inc. | 11/08/2012SE |
Questions and answers
When was Stoploss Jones Tube cleared by the FDA?
Stoploss Jones Tube (K140290) received a 510(k) decision of Substantially Equivalent on December 2, 2014, 300 days after the submission was received.
What is the product code of K140290?
The FDA product code is OKS – Lacrimal Stents And Intubation Sets, a Unclassified device.