Nunchaku

FDA 510(k) K161373 · Fci (France Chirurgie Instrumentation)

Substantially Equivalent

510(k) numberK161373

Submission

Device name
Nunchaku
Applicant
Fci (France Chirurgie Instrumentation)
Paris, FR
Received
May 17, 2016
Decision date
November 3, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OKS – Lacrimal Stents And Intubation Sets
Device class
Unclassified
Implant
Yes

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…

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K170247Lacriflow CLOKS · Special Kaneka Pharma America, LLC04/18/2017SE
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K130375Self-Retaining Bicanaliculus Intubaton Set IIOKS · Traditional Fci Sas (France Chirurgie Instrumentation)12/04/2013SE
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K120886LacrifastOKS · Traditional Hiroyasu Higuchi12/17/2012SE
K113316DCS Lacrimal StentOKS · Traditional Dcs Surgical, Inc.11/08/2012SE

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K201606LacriJet®OKS · Traditional 12/18/2020SE

Questions and answers

When was Nunchaku cleared by the FDA?

Nunchaku (K161373) received a 510(k) decision of Substantially Equivalent on November 3, 2016, 170 days after the submission was received.

What is the product code of K161373?

The FDA product code is OKS – Lacrimal Stents And Intubation Sets, a Unclassified device.