BEUDAMED
    Product Code: OKS FDA unclassified

    Lacrimal Stents And Intubation Sets

    Unknown

    Lacrimal Stents and Intubation Sets (product code OKS) are unclassified devices reviewed by the Ophthalmic (OP) panel that have undergone 510(k) review but remain without a final classification. They are intended to repair the lacrimal drainage system and are indicated for the treatment of epiphora in infants and adults, canalicular pathologies such as stenosis, obstruction or laceration, conditions requiring dacryocystorhinostomy, or nasolacrimal duct imperforation in infants. Notably, the device carries an implant flag, indicating it is intended to be placed within or on the body.

    View on FDA
    510(k)s
    31
    FEI Numbers
    19
    Registration Numbers
    20
    Unique Applicants
    19
    Years Active
    33

    Basic Information

    Product Code
    OKS
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    Unclassified Reason

    1

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 31 510(k) clearances via K numbers.

    K Number Device Name
    K201892 Ritleng®+ and Ritleng®+ PVP
    K201606 LacriJet®
    K170247 Lacriflow CL
    K161373 Nunchaku
    K160710 Oasis Lacrimal Intubation Set
    K142914 DacryoCATH
    K140290 STOPLOSS JONES TUBE
    K130375 SELF-RETAINING BICANALICULUS INTUBATON SET II
    K123831 OPHTACATH KIT
    K120886 LACRIFAST
    K113316 DCS LACRIMAL STENT
    K113867 LACRICATH LACRIMAL DUCT CATHETER
    K113508 DACRYOCATH
    K121142 CRAWFORD BIOCANALICULUS INTUBATION
    K113536 MASTERKA 40 MASTERKA 35 MASTERKA 30
    K113118 STENTUBE LACRIMAL INTUBATION SET
    K061404 MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
    K041869 SELF RETAINING BICANALICULUS INTUBATION SET
    K023758 BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
    K030353 MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
    K012108 MEDPOR COATED TEAR DRAIN
    K991238 FCI CRAWFORD PROBE INTUBATION SETS
    K990672 LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
    K973633 ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
    K973872 ATRION MEDICAL COATED LACRIMAL INTUBATION SET
    K962151 RYDER LACRIMAL INTUBATIONSET
    K955671 RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
    K935233 IOLAB LACRIMAL DUCT CATHETER
    K940508 OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
    K911109 OPHTA SIL (R), LACHRYMAL INTUBATION SETS
    K883233 EV MONOCANALICULAR STENT (TM)

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.