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- MiscellaneousMiscellaneous
- OGOIntraocular Pressure Lowering Implant3Product Code
- QQUDigital Therapy Device For Amblyopia2Product Code
- HPXLens, Contact (Polymethylmethacrylate)UProduct Code
- LOGCatheter, Balloon For Retinal Reattachment3Product Code
- LOHSystem, Identification, Contact Lens3Product Code
- LOILaser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary3Product Code
- LQBMedical Computers And Software For Ophthalmic Use3Product Code
- LQEImplant, Corneal, Refractive3Product Code
- LXQCup, EyeUProduct Code
- LYXMedia, Corneal StorageUProduct Code
- LZQTissue Adhesive For Ophthalmic Use3Product Code
- LZRUltrasound, Cyclodestructive3Product Code
- LZSExcimer Laser System3Product Code
- LZUPlug, PunctumUProduct Code
- MRJRing, Endocapsular3Product Code
- MSISolution, Cleaning / Lubricating, Artificial Eye3Product Code
- MTALens, Intraocular, Phakic3Product Code
- MURGraft, Sclera, Reinforcement3Product Code
- MWDElectrosurgical, Radio Frequency, Refractive Correction3Product Code
- NBFProsthesis, RetinalFProduct Code
- NCJTelescope, Implantable, Miniature3Product Code
- ODKRefractive Corneal ImplantFProduct Code
- OKSLacrimal Stents And Intubation SetsUProduct Code
- K201892Ritleng®+ and Ritleng®+ PVPUCleared 510(K)
- K201606LacriJet®UCleared 510(K)
- K170247Lacriflow CLUCleared 510(K)
- K161373NunchakuUCleared 510(K)
- K160710Oasis Lacrimal Intubation SetUCleared 510(K)
- K142914DacryoCATHUCleared 510(K)
- K140290STOPLOSS JONES TUBEUCleared 510(K)
- K130375SELF-RETAINING BICANALICULUS INTUBATON SET IIUCleared 510(K)
- K123831OPHTACATH KITUCleared 510(K)
- K120886LACRIFASTUCleared 510(K)
- K113316DCS LACRIMAL STENTUCleared 510(K)
- K113867LACRICATH LACRIMAL DUCT CATHETERUCleared 510(K)
- K113508DACRYOCATHUCleared 510(K)
- K121142CRAWFORD BIOCANALICULUS INTUBATIONUCleared 510(K)
- K113536MASTERKA 40 MASTERKA 35 MASTERKA 30UCleared 510(K)
- K113118STENTUBE LACRIMAL INTUBATION SETUCleared 510(K)
- K061404MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICEUCleared 510(K)
- K041869SELF RETAINING BICANALICULUS INTUBATION SETUCleared 510(K)
- K023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)UCleared 510(K)
- K030353MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETSUCleared 510(K)
- K012108MEDPOR COATED TEAR DRAINUCleared 510(K)
- K991238FCI CRAWFORD PROBE INTUBATION SETSUCleared 510(K)
- K990672LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SETUCleared 510(K)
- K973633ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SETUCleared 510(K)
- K973872ATRION MEDICAL COATED LACRIMAL INTUBATION SETUCleared 510(K)
- K962151RYDER LACRIMAL INTUBATIONSETUCleared 510(K)
- K955671RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)UCleared 510(K)
- K935233IOLAB LACRIMAL DUCT CATHETERUCleared 510(K)
- K940508OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)UCleared 510(K)
- K911109OPHTA SIL (R), LACHRYMAL INTUBATION SETSUCleared 510(K)
- K883233EV MONOCANALICULAR STENT (TM)UCleared 510(K)
- OTLFemtosecond Laser System For Refractive Correction3Product Code
- OXWStimulator, Electrical, Transcutaneous, For Diabetic RetinopathyNProduct Code
- PFZOphthalmic Sealant3Product Code
- QBTArtificial Iris3Product Code
- QITDaily Wear Soft Contact Lens To Reduce The Progression Of Myopia3Product Code
- QCWCorneal Storage Media With Preservatives Including Anti-Fungal2Product Code
- SAXHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device2Product Code
- QQJApplicator, Negative Pressure, External, Ocular2Product Code
- SDELight Based Device For Dry Age-Related Macular Degeneration2Product Code
- QURPrescription Spectacle Lenses To Reduce The Progression Of Myopia2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
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- UnknownReview Panel
DACRYOCATH
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K113508
- 510(k) Type
- Traditional
- Applicant
- Armadillo Biomedical, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/31/2012
- Days to Decision
- 277 days
- Submission Type
- Summary