Cleared Traditional

K130375 - SELF-RETAINING BICANALICULUS INTUBATON SET II

K130375 · Fci Sas (France Chirurgie Instrumentation) · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Dec 2013
Decision
293d
Days
-
Risk

K130375 is an FDA 510(k) clearance for the SELF-RETAINING BICANALICULUS INTUBATON SET II. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Fci Sas (France Chirurgie Instrumentation) (Cincinnati, US). The FDA issued a Cleared decision on December 4, 2013 after a review of 293 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.

View all Fci Sas (France Chirurgie Instrumentation) devices

FDA 510(k) Submission Details - K130375

510(k) Number K130375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2013
Decision Date December 04, 2013
Days to Decision 293 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
183d slower than avg
Panel avg: 110d · This submission: 293d
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

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