Cleared Traditional

K041869 - SELF RETAINING BICANALICULUS INTUBATION SET

K041869 · Fci Ophthalmics, Inc. · Ophthalmic device
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Nov 2004
Decision
132d
Days
-
Risk

K041869 is an FDA 510(k) clearance for the SELF RETAINING BICANALICULUS INTUBATION SET. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on November 18, 2004 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Fci Ophthalmics, Inc. devices

FDA 510(k) Submission Details - K041869

510(k) Number K041869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 110d · This submission: 132d
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 8
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K041869.
LacriJet®
K201606 · Fci (France Chirurgie Instrumentation) Sas · Dec 2020
LACRICATH LACRIMAL DUCT CATHETER
K113867 · Quest Medical, Inc. · Oct 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · Quest Medical, Inc. · Jul 2012
MEDPOR COATED TEAR DRAIN
K012108 · Porex Surgical, Inc. · Dec 2001
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
K973633 · Atrion Medical Products, Inc. · Jan 1998
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K973872 · Atrion Medical Products, Inc. · Jan 1998