DacryoCATH
FDA 510(k) K142914 · Armadillo Biomedical, LLC
510(k) numberK142914
Submission
- Device name
- DacryoCATH
- Applicant
- Armadillo Biomedical, LLC
Encino, CA, US - Received
- October 7, 2014
- Decision date
- January 12, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K161373 | NunchakuOKS · Traditional | Fci (France Chirurgie Instrumentation) | 11/03/2016SE |
| K160710 | Oasis Lacrimal Intubation SetOKS · Traditional | Anodyne | 05/13/2016SESK |
| 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 |
| K113316 | DCS Lacrimal StentOKS · Traditional | Dcs Surgical, Inc. | 11/08/2012SE |
More from Dcs Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113508 | DacryocathOKS · Traditional | 08/31/2012SE |
Questions and answers
When was DacryoCATH cleared by the FDA?
DacryoCATH (K142914) received a 510(k) decision of Substantially Equivalent on January 12, 2015, 97 days after the submission was received.
What is the product code of K142914?
The FDA product code is OKS – Lacrimal Stents And Intubation Sets, a Unclassified device.