FDA 510(k) Applications for Medical Device Product Code "OKS"
(Lacrimal Stents And Intubation Sets)

FDA 510(k) Number Applicant Device Name Decision Date
K160710 ANODYNE Oasis Lacrimal Intubation Set 05/13/2016
K113508 ARMADILLO BIOMEDICAL, LLC DACRYOCATH 08/31/2012
K142914 ARMADILLO BIOMEDICAL, LLC DacryoCATH 01/12/2015
K973872 ATRION MEDICAL PRODUCTS, INC. ATRION MEDICAL COATED LACRIMAL INTUBATION SET 01/08/1998
K973633 ATRION MEDICAL PRODUCTS, INC. ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET 01/16/1998
K113316 DCS SURGICAL INC DCS LACRIMAL STENT 11/08/2012
K030353 EAGLE VISION, INC. MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS 04/25/2003
K161373 FCI (FRANCE CHIRURGIE INSTRUMENTATION) Nunchaku 11/03/2016
K201606 FCI (France Chirurgie Instrumentation) SAS LacriJet« 12/18/2020
K201892 FCI (France Chirurgie Instrumentation) SAS Ritleng«+ and Ritleng«+ PVP 03/11/2021
K023758 FCI OPHTHALMICS, INC. BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) 09/17/2003
K991238 FCI OPHTHALMICS, INC. FCI CRAWFORD PROBE INTUBATION SETS 07/08/1999
K061404 FCI OPHTHALMICS, INC. MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE 08/07/2006
K041869 FCI OPHTHALMICS, INC. SELF RETAINING BICANALICULUS INTUBATION SET 11/18/2004
K121142 FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) CRAWFORD BIOCANALICULUS INTUBATION 08/09/2012
K113536 FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) MASTERKA 40 MASTERKA 35 MASTERKA 30 08/03/2012
K130375 FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) SELF-RETAINING BICANALICULUS INTUBATON SET II 12/04/2013
K123831 FRANCE CHIRURGAE INSTRUMENTATION OPHTACATH KIT 07/29/2013
K955671 G.W.B. INTL., LTD. RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) 03/06/1996
K120886 HIROYASU HIGUCHI LACRIFAST 12/17/2012
K990672 HURRICANE MEDICAL LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET 05/18/1999
K170247 KANEKA PHARMA AMERICA LLC Lacriflow CL 04/18/2017
K140290 LJT SURGICAL LTD STOPLOSS JONES TUBE 12/02/2014
K012108 POREX SURGICAL, INC. MEDPOR COATED TEAR DRAIN 12/19/2001
K113867 QUEST MEDICAL, INC. LACRICATH LACRIMAL DUCT CATHETER 10/19/2012
K113118 QUEST MEDICAL, INC. STENTUBE LACRIMAL INTUBATION SET 07/31/2012
K962151 RYDER INTL. CORP. RYDER LACRIMAL INTUBATIONSET 09/18/1996


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