Ritleng®+ and Ritleng®+ PVP

FDA 510(k) K201892 · Fci (France Chirurgie Instrumentation) Sas

Substantially Equivalent

510(k) numberK201892

Submission

Device name
Ritleng®+ and Ritleng®+ PVP
Applicant
Fci (France Chirurgie Instrumentation) Sas
Paris, FR
Received
July 8, 2020
Decision date
March 11, 2021
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…

Other 510(k)s with product code OKS

510(k)DeviceApplicantDecision
K201606LacriJet®OKS · Traditional Fci (France Chirurgie Instrumentation) Sas12/18/2020SE
K170247Lacriflow CLOKS · Special Kaneka Pharma America, LLC04/18/2017SE
K161373NunchakuOKS · Traditional Fci (France Chirurgie Instrumentation)11/03/2016SE
K160710Oasis Lacrimal Intubation SetOKS · Traditional Anodyne05/13/2016SESK
K142914DacryoCATHOKS · Special Armadillo Biomedical, LLC01/12/2015SE
K140290Stoploss Jones TubeOKS · Traditional Ljt Surgical, Ltd.12/02/2014SE
K130375Self-Retaining Bicanaliculus Intubaton Set IIOKS · Traditional Fci Sas (France Chirurgie Instrumentation)12/04/2013SE
K123831Ophtacath KitOKS · Traditional France Chirurgae Instrumentation07/29/2013SE
K120886LacrifastOKS · Traditional Hiroyasu Higuchi12/17/2012SE
K113316DCS Lacrimal StentOKS · Traditional Dcs Surgical, Inc.11/08/2012SE

More from Dcs Surgical, Inc.

510(k)DeviceDecision
K212741EzyporHPZ · Traditional 06/24/2022SE
K203569Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid ImplantsNCB · Traditional 06/11/2021SE
K201606LacriJet®OKS · Traditional 12/18/2020SE
K161373NunchakuOKS · Traditional 11/03/2016SE

Questions and answers

When was Ritleng®+ and Ritleng®+ PVP cleared by the FDA?

Ritleng®+ and Ritleng®+ PVP (K201892) received a 510(k) decision of Substantially Equivalent on March 11, 2021, 246 days after the submission was received.

What is the product code of K201892?

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