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510(k) K201892

Device
Ritleng®+ And Ritleng®+ PVP
Applicant
FCI (France Chirurgie Instrumentation) SAS
510(k) number
K201892
Product code
OKS  
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-11
Date received
2020-07-08
Regulation
510(k) Premarket Notification
Classification name
Lacrimal Stents And Intubation Sets
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Ophthalmic
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Thierry Fetick
Address
20-22 Rue Louis Armand Paris FR 75015 75015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OKS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201606LacriJet®Fci (France Chirurgie Instrumentation) Sas2020-12-18
K170247Lacriflow CLKaneka Pharma America, LLC2017-04-18
K161373NunchakuFci (France Chirurgie Instrumentation)2016-11-03
K160710Oasis Lacrimal Intubation SetAnodyne2016-05-13
K142914DacryoCATHArmadillo Biomedical, LLC2015-01-12
K140290STOPLOSS JONES TUBELjt Surgical, Ltd.2014-12-02
K130375SELF-RETAINING BICANALICULUS INTUBATON SET IIFci Sas (France Chirurgie Instrumentation)2013-12-04
K123831OPHTACATH KITFrance Chirurgae Instrumentation2013-07-29
K120886LACRIFASTHiroyasu Higuchi2012-12-17
K113316DCS LACRIMAL STENTDcs Surgical, Inc.2012-11-08
K113867LACRICATH LACRIMAL DUCT CATHETERQuest Medical, Inc.2012-10-19
K113508DACRYOCATHArmadillo Biomedical, LLC2012-08-31
K121142CRAWFORD BIOCANALICULUS INTUBATIONFci Sas (France Chirurgie Instrumentation)2012-08-09
K113536MASTERKA 40 MASTERKA 35 MASTERKA 30Fci Sas (France Chirurgie Instrumentation)2012-08-03
K113118STENTUBE LACRIMAL INTUBATION SETQuest Medical, Inc.2012-07-31

Legacy Summary#

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FDA Review#

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