510(k) K113508
K113508 is an FDA 510(k) premarket notification submitted by Armadillo Biomedical, LLC for the device "DACRYOCATH". The FDA issued a decision of Substantially Equivalent on August 31, 2012. The device falls under product code OKS (Lacrimal Stents And Intubation Sets), a Class U device. Armadillo Biomedical, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2012
- Date Received
- November 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lacrimal Stents And Intubation Sets
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type
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.