Cleared Traditional

K161373 - Nunchaku (FDA 510(k) Clearance)

K161373 · Fci (France Chirurgie Instrumentation) · Ophthalmic device
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Nov 2016
Decision
170d
Days
-
Risk

K161373 is an FDA 510(k) clearance for the Nunchaku. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Fci (France Chirurgie Instrumentation) (Paris, FR). The FDA issued a Cleared decision on November 3, 2016 after a review of 170 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 (France Chirurgie Instrumentation) devices

Submission Details

510(k) Number K161373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2016
Decision Date November 03, 2016
Days to Decision 170 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
60d slower than avg
Panel avg: 110d · This submission: 170d
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.