Cleared Traditional

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (K061404) - FDA 510(k) Clearance

K061404 · Fci Ophthalmics, Inc. · Ophthalmic device
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Aug 2006
Decision
80d
Days
-
Risk

K061404 is an FDA 510(k) clearance for the MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on August 7, 2006 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fci Ophthalmics, Inc. devices

Submission Details

510(k) Number K061404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2006
Decision Date August 07, 2006
Days to Decision 80 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 110d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

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.