Cleared Traditional

MASTERKA 40 MASTERKA 35 MASTERKA 30 (K113536) - FDA 510(k) Clearance

K113536 · Fci Sas (France Chirurgie Instrumentation) · Ophthalmic device
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Aug 2012
Decision
247d
Days
-
Risk

K113536 is an FDA 510(k) clearance for the MASTERKA 40 MASTERKA 35 MASTERKA 30. 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 August 3, 2012 after a review of 247 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

Submission Details

510(k) Number K113536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date August 03, 2012
Days to Decision 247 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
137d slower than avg
Panel avg: 110d · This submission: 247d
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.