Product code OKS
- Device name
- Lacrimal Stents And Intubation Sets
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201892 | Ritleng®+ and Ritleng®+ PVP | Fci (France Chirurgie Instrumentation) Sas | 2021-03-11 |
| K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | 2020-12-18 |
| K170247 | Lacriflow CL | Kaneka Pharma America, LLC | 2017-04-18 |
| K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016-11-03 |
| K160710 | Oasis Lacrimal Intubation Set | Anodyne | 2016-05-13 |
| K142914 | DacryoCATH | Armadillo Biomedical, LLC | 2015-01-12 |
| K140290 | STOPLOSS JONES TUBE | Ljt Surgical, Ltd. | 2014-12-02 |
| K130375 | SELF-RETAINING BICANALICULUS INTUBATON SET II | Fci Sas (France Chirurgie Instrumentation) | 2013-12-04 |
| K123831 | OPHTACATH KIT | France Chirurgae Instrumentation | 2013-07-29 |
| K120886 | LACRIFAST | Hiroyasu Higuchi | 2012-12-17 |
| K113316 | DCS LACRIMAL STENT | Dcs Surgical, Inc. | 2012-11-08 |
| K113867 | LACRICATH LACRIMAL DUCT CATHETER | Quest Medical, Inc. | 2012-10-19 |
| K113508 | DACRYOCATH | Armadillo Biomedical, LLC | 2012-08-31 |
| K121142 | CRAWFORD BIOCANALICULUS INTUBATION | Fci Sas (France Chirurgie Instrumentation) | 2012-08-09 |
| K113536 | MASTERKA 40 MASTERKA 35 MASTERKA 30 | Fci Sas (France Chirurgie Instrumentation) | 2012-08-03 |
| K113118 | STENTUBE LACRIMAL INTUBATION SET | Quest Medical, Inc. | 2012-07-31 |
| K061404 | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | Fci Ophthalmics, Inc. | 2006-08-07 |
| K041869 | SELF RETAINING BICANALICULUS INTUBATION SET | Fci Ophthalmics, Inc. | 2004-11-18 |
| K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | Fci Ophthalmics, Inc. | 2003-09-17 |
| K030353 | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS | Eagle Vision, Inc. | 2003-04-25 |
| K012108 | MEDPOR COATED TEAR DRAIN | Porex Surgical, Inc. | 2001-12-19 |
| K991238 | FCI CRAWFORD PROBE INTUBATION SETS | Fci Ophthalmics, Inc. | 1999-07-08 |
| K990672 | LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET | Hurricane Medical | 1999-05-18 |
| K973633 | ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET | Atrion Medical Products, Inc. | 1998-01-16 |
| K973872 | ATRION MEDICAL COATED LACRIMAL INTUBATION SET | Atrion Medical Products, Inc. | 1998-01-08 |
| K962151 | RYDER LACRIMAL INTUBATIONSET | Ryder Intl. Corp. | 1996-09-18 |
| K955671 | RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) | G.W.B. Intl., Ltd. | 1996-03-06 |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | Chiron Vision Corp. | 1994-09-15 |
| K940508 | OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) | G.W.B. Intl., Ltd. | 1994-05-04 |
| K911109 | OPHTA SIL (R), LACHRYMAL INTUBATION SETS | G.W.B. Intl., Ltd. | 1991-05-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 13700773731975 | STOPLOSS® JONES TUBE 3,5 X 17 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732118 | STOPLOSS® JONES TUBE 4 X 17 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732101 | STOPLOSS® JONES TUBE 4 X 16 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732095 | STOPLOSS® JONES TUBE 4 X 15 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732088 | STOPLOSS® JONES TUBE 4 X 14 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732071 | STOPLOSS® JONES TUBE 4 X 13 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732064 | STOPLOSS® JONES TUBE 4 X 12 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732057 | STOPLOSS® JONES TUBE 4 X 11 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732040 | STOPLOSS® JONES TUBE 4 X 10 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732033 | STOPLOSS® JONES TUBE 4 X 9 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732026 | STOPLOSS® JONES TUBE 3,5 X 22 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732019 | STOPLOSS® JONES TUBE 3,5 X 21 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773732002 | STOPLOSS® JONES TUBE 3,5 X 20 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773731999 | STOPLOSS® JONES TUBE 3,5 X 19 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773731982 | STOPLOSS® JONES TUBE 3,5 X 18 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773731968 | STOPLOSS® JONES TUBE 3,5 X 16 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773731937 | STOPLOSS® JONES TUBE 3,5 X 15 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773731920 | STOPLOSS® JONES TUBE 3,5 X 14 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773730817 | STOPLOSS® JONES TUBE INTRODUCER SET | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773729699 | STOPLOSS® JONES TUBE 3,5 X 13 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773729682 | STOPLOSS® JONES TUBE 3,5 X 12 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773729675 | STOPLOSS® JONES TUBE 3,5 X 11 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773729668 | STOPLOSS® JONES TUBE 3,5 X 10 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| 13700773729651 | STOPLOSS® JONES TUBE 3,5 X 9 MM | FCI S A S FCI 20 22 | 2026-04-20 |
| M6332801900 | JEDMED | JEDMED INSTRUMENT COMPANY | 2022-12-19 |
| M6332801860 | JEDMED | JEDMED INSTRUMENT COMPANY | 2022-12-19 |
| 10634624715278 | Lacrimal Intubation Set, Crawford Type | QUEST MEDICAL INC | 2019-10-10 |
| 10634624810201 | LacriCATH | QUEST MEDICAL INC | 2016-10-14 |
| 10634624810195 | LacriCATH | QUEST MEDICAL INC | 2016-10-14 |
| 10634624810188 | LacriCATH | QUEST MEDICAL INC | 2016-10-14 |