Cleared Traditional

K061404 - MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE

K061404 · Fci Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K061404

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.

OKS Device Classification - Class 0,

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.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

All 29
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K061404.
CRAWFORD BIOCANALICULUS INTUBATION
K121142 · Fci Sas (France Chirurgie Instrumentation) · Aug 2012
MASTERKA 40 MASTERKA 35 MASTERKA 30
K113536 · Fci Sas (France Chirurgie Instrumentation) · Aug 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · Quest Medical, Inc. · Jul 2012
SELF RETAINING BICANALICULUS INTUBATION SET
K041869 · Fci Ophthalmics, Inc. · Nov 2004
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
K023758 · Fci Ophthalmics, Inc. · Sep 2003
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K030353 · Eagle Vision, Inc. · Apr 2003
K061404 · MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
Download PDF Fci Ophthalmics, Inc.