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510(k) K160710

Oasis Lacrimal Intubation Set by Anodyne — Product Code OKS

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 13, 2016
Date Received
March 15, 2016
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.

Other clearances by Anodyne

  • K902141 — ANOLIFT - PORTABLE & ANOLIFT - GANTRY (September 12, 1990)

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