Cleared Traditional

K123831 - OPHTACATH KIT (FDA 510(k) Clearance)

K123831 · France Chirurgae Instrumentation · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jul 2013
Decision
229d
Days
-
Risk

K123831 is an FDA 510(k) clearance for the OPHTACATH KIT. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by France Chirurgae Instrumentation (Cincinnati, US). The FDA issued a Cleared decision on July 29, 2013 after a review of 229 days - an extended review 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: 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.

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Submission Details

510(k) Number K123831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2012
Decision Date July 29, 2013
Days to Decision 229 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 110d · This submission: 229d
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.