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OKS

31 FDA 510(k) clearances · Product code

166 daysmedian time to decision
300 days90th percentile
31clearances measured

FDA profile

Official device name
Lacrimal Stents And Intubation Sets
Device class
Unclassified
Medical specialty
Unknown
Flags
Implant
FDA 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.
Adverse events (MAUDE)
2014: 8 · 2015: 14 · 2016: 21 · 2017: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ritleng®+ and Ritleng®+ PVP (K201892)Fci (France Chirurgie Instrumentation) Sas2021-03-11
LacriJet® (K201606)Fci (France Chirurgie Instrumentation) Sas2020-12-18
Lacriflow CL (K170247)Kaneka Pharma America, LLC2017-04-18
Nunchaku (K161373)Fci (France Chirurgie Instrumentation)2016-11-03
Oasis Lacrimal Intubation Set (K160710)Anodyne2016-05-13
DacryoCATH (K142914)Armadillo Biomedical, LLC2015-01-12
STOPLOSS JONES TUBE (K140290)Ljt Surgical, Ltd.2014-12-02
SELF-RETAINING BICANALICULUS INTUBATON SET II (K130375)Fci Sas (France Chirurgie Instrumentation)2013-12-04
OPHTACATH KIT (K123831)France Chirurgae Instrumentation2013-07-29
LACRIFAST (K120886)Hiroyasu Higuchi2012-12-17
DCS LACRIMAL STENT (K113316)Dcs Surgical, Inc.2012-11-08
LACRICATH LACRIMAL DUCT CATHETER (K113867)Quest Medical, Inc.2012-10-19
DACRYOCATH (K113508)Armadillo Biomedical, LLC2012-08-31
CRAWFORD BIOCANALICULUS INTUBATION (K121142)Fci Sas (France Chirurgie Instrumentation)2012-08-09
MASTERKA 40 MASTERKA 35 MASTERKA 30 (K113536)Fci Sas (France Chirurgie Instrumentation)2012-08-03
STENTUBE LACRIMAL INTUBATION SET (K113118)Quest Medical, Inc.2012-07-31
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (K061404)Fci Ophthalmics, Inc.2006-08-07
SELF RETAINING BICANALICULUS INTUBATION SET (K041869)Fci Ophthalmics, Inc.2004-11-18
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (K023758)Fci Ophthalmics, Inc.2003-09-17
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS (K030353)Eagle Vision, Inc.2003-04-25
MEDPOR COATED TEAR DRAIN (K012108)Porex Surgical, Inc.2001-12-19
FCI CRAWFORD PROBE INTUBATION SETS (K991238)Fci Ophthalmics, Inc.1999-07-08
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET (K990672)Hurricane Medical1999-05-18
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (K973633)Atrion Medical Products, Inc.1998-01-16
ATRION MEDICAL COATED LACRIMAL INTUBATION SET (K973872)Atrion Medical Products, Inc.1998-01-08
RYDER LACRIMAL INTUBATIONSET (K962151)Ryder Intl. Corp.1996-09-18
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) (K955671)G.W.B. Intl., Ltd.1996-03-06
IOLAB LACRIMAL DUCT CATHETER (K935233)Chiron Vision Corp.1994-09-15
OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) (K940508)G.W.B. Intl., Ltd.1994-05-04
OPHTA SIL (R), LACHRYMAL INTUBATION SETS (K911109)G.W.B. Intl., Ltd.1991-05-01
EV MONOCANALICULAR STENT (TM) (K883233)Eagle Vision, Inc.1988-08-22

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Every clearance here is in the API, with alerts when new ones post.