Cleared Traditional

Oasis Lacrimal Intubation Set

K160710 · Anodyne · Ophthalmic
May 2016
Decision
59d
Days
—
Risk

About This 510(k) Submission

K160710 is an FDA 510(k) clearance for the Oasis Lacrimal Intubation Set, a Lacrimal Stents And Intubation Sets, submitted by Anodyne (O' Fallon, US). The FDA issued a Cleared decision on May 13, 2016, 59 days after receiving the submission on March 15, 2016. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K160710 FDA.gov
FDA Decision Cleared SESK
Date Received March 15, 2016
Decision Date May 13, 2016
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code OKS — Lacrimal Stents And Intubation Sets
Device Class —
Definition 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.