Submission Details
| 510(k) Number | K161373 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Nunchaku
Nov 2016
Decision
170d
Days
—
Risk
About This 510(k) Submission
K161373 is an FDA 510(k) clearance for the Nunchaku, a Lacrimal Stents And Intubation Sets, submitted by Fci (France Chirurgie Instrumentation) (Paris, FR). The FDA issued a Cleared decision on November 3, 2016, 170 days after receiving the submission on May 17, 2016. This device falls under the Ophthalmic review panel.
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. |
Manufacturer
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