Cleared Traditional

DCS LACRIMAL STENT (K113316) - FDA 510(k) Clearance

K113316 · Dcs Surgical, Inc. · Ophthalmic device
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Nov 2012
Decision
365d
Days
-
Risk

K113316 is an FDA 510(k) clearance for the DCS LACRIMAL STENT. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Dcs Surgical, Inc. (Boulder, US). The FDA issued a Cleared decision on November 8, 2012 after a review of 365 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.

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Submission Details

510(k) Number K113316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2011
Decision Date November 08, 2012
Days to Decision 365 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
255d slower than avg
Panel avg: 110d · This submission: 365d
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.