Cleared Traditional

BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (K023758) - FDA 510(k) Clearance

K023758 · Fci Ophthalmics, Inc. · Ophthalmic device
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Sep 2003
Decision
313d
Days
-
Risk

K023758 is an FDA 510(k) clearance for the BECKER TRANSNASAL LACRIMAL (INTUBATION SETS). Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K023758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2002
Decision Date September 17, 2003
Days to Decision 313 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
203d slower than avg
Panel avg: 110d · This submission: 313d
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.