Cleared Traditional

LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET

K990672 · Hurricane Medical · Ophthalmic

May 1999

Decision

77d

Days

—

Risk

About This 510(k) Submission

K990672 is an FDA 510(k) clearance for the LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET, a Lacrimal Stents And Intubation Sets, submitted by Hurricane Medical (Bradenton, US). The FDA issued a Cleared decision on May 18, 1999, 77 days after receiving the submission on March 2, 1999. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K990672 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1999
Decision Date	May 18, 1999
Days to Decision	77 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.