Cleared Traditional

K161373 - Nunchaku

K161373 · Fci (France Chirurgie Instrumentation) · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K161373

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 110d · This submission: 170d
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 Consultant

Clinical Research Consultants, Inc.
BARBARA S. FANT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

All 24
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K161373.
Ritleng®+ and Ritleng®+ PVP
K201892 · Fci (France Chirurgie Instrumentation) Sas · Mar 2021
LacriJet®
K201606 · Fci (France Chirurgie Instrumentation) Sas · Dec 2020
Lacriflow CL
K170247 · Kaneka Pharma America, LLC · Apr 2017
Oasis Lacrimal Intubation Set
K160710 · Anodyne · May 2016
DacryoCATH
K142914 · Armadillo Biomedical, LLC · Jan 2015
STOPLOSS JONES TUBE
K140290 · Ljt Surgical, Ltd. · Dec 2014