Cleared Traditional

K041869 - SELF RETAINING BICANALICULUS INTUBATION SET
(FDA 510(k) Clearance)

K041869 · Fci Ophthalmics, Inc. · Ophthalmic

Nov 2004

Decision

132d

Days

—

Risk

K041869 is an FDA 510(k) clearance for the SELF RETAINING BICANALICULUS INTUBATION SET, a Lacrimal Stents And Intubation Sets, submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on November 18, 2004, 132 days after receiving the submission on July 9, 2004. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K041869 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2004
Decision Date	November 18, 2004
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement

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.