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Data / Medical devices / United States / Katena Products, Inc.

Katena Products, Inc.: FDA-registered device maker in Parsippany, NJ, United States, 17 510(k) clearances

Katena Products, Inc. is registered with the FDA (registration 3015177648) in Parsippany, NJ, United States. It lists 65 device types. The FDA files 17 510(k) clearances under its listings, the newest dated October 13, 2015. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Katena Products, Inc.
FDA registration number
3015177648
Address
6 Campus Drive Suite 310, Parsippany, NJ, United States, 07054
Owner or operator
Corza Medical, Inc. (2242450)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 8, 1977
Registered through
2026
Brand names listed
AK Step Knife Double Footplate, Barron Donor Corneal Punches, Barron Radial Vacuum Trephines, Barron Vacuum Donor Punches, Blink, Castroviejo Lid Speculum, Clear Corneal Diamond Knife, Diamond Knife Crescent and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Ocular PressureLCC2Specification developeraccessdata.fda.gov
Blade, ScalpelGES1Specification developeraccessdata.fda.gov
Burr, Corneal, Battery Powered, Rust Ring RemovalOHW1Specification developeraccessdata.fda.gov
Burr, Corneal, ManualHOF1Specification developeraccessdata.fda.gov
Caliper, OphthalmicHOE1Specification developeraccessdata.fda.gov
Cannula, OphthalmicHMX1Complaint file establishment, Specification developeraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Specification developeraccessdata.fda.gov
Clamp, Eyelid, OphthalmicHOD1Specification developeraccessdata.fda.gov
Clamp, Muscle, OphthalmicHOB1Complaint file establishment, Specification developeraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Clip, Iris RetractorHOC1Specification developeraccessdata.fda.gov
Conformer, OphthalmicHQN2Specification developeraccessdata.fda.gov
Curette, OphthalmicHNZ1Specification developeraccessdata.fda.gov
CystotomeHNY1Manufacturer, Specification developeraccessdata.fda.gov
Depressor, OrbitalHNX1Specification developeraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Specification developeraccessdata.fda.gov
Device, Measuring, Lens Radius, OphthalmicHLF1Specification developeraccessdata.fda.gov
Dilator, LachrymalHNW1Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Complaint file establishmentaccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Specification developeraccessdata.fda.gov
Folders And Injectors, Intraocular Lens (Iol)MSS1Specification developeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Specification developeraccessdata.fda.gov
Forceps, OphthalmicHNR1Complaint file establishment, Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Specification developeraccessdata.fda.gov
HemostatHRQ1Specification developeraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Hook, OphthalmicHNQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Implant, Eye SphereHPZ2Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Introducer, SphereHNP1Complaint file establishment, Specification developeraccessdata.fda.gov
Knife, OphthalmicHNN1Complaint file establishment, Specification developeraccessdata.fda.gov
Knife, SurgicalEMF1Specification developeraccessdata.fda.gov
Lacrimal Stents And Intubation SetsOKSUSpecification developeraccessdata.fda.gov
Lens, Condensing, DiagnosticHJL1Specification developeraccessdata.fda.gov
Lens, Contact, Polymethylmethacrylate, DiagnosticHJK2Specification developeraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Specification developeraccessdata.fda.gov
Marker, OcularHMR1Specification developeraccessdata.fda.gov
Marker, ScleraHMQ1Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Specification developeraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Specification developeraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Specification developeraccessdata.fda.gov
Plug, PunctumLZUUSpecification developeraccessdata.fda.gov
Prism, GonioscopicHKS1Specification developeraccessdata.fda.gov
Probe, LachrymalHNL1Complaint file establishment, Specification developeraccessdata.fda.gov
Probe, TrabeculotomyHNK1Specification developeraccessdata.fda.gov
Prosthesis, Eyelid Spacer/Graft, BiologicNXM2Specification developeraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Specification developeraccessdata.fda.gov
Retractor, OphthalmicHNI1Specification developeraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Specification developeraccessdata.fda.gov
Rongeur, Lachrymal SacHNG1Specification developeraccessdata.fda.gov
Scissors, General, SurgicalLRW1Specification developeraccessdata.fda.gov
Scissors, OphthalmicHNF1Complaint file establishment, Specification developeraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Specification developeraccessdata.fda.gov
Spatula, OphthalmicHND1Complaint file establishment, Specification developeraccessdata.fda.gov
Specula, OphthalmicHNC1Complaint file establishment, Specification developeraccessdata.fda.gov
Speculum, EntEPY1Specification developeraccessdata.fda.gov
Sponge, OphthalmicHOZ2Specification developeraccessdata.fda.gov
Spoon, OphthalmicHNB1Complaint file establishment, Specification developeraccessdata.fda.gov
Spud, OphthalmicHNA1Specification developeraccessdata.fda.gov
Surgical Eye TrayPZG1Specification developeraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Specification developeraccessdata.fda.gov
Tonometer, ManualHKY2Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 13, 2015K152308Sensor Medical Single Use Tonometer PrismHKYSubstantially EquivalentSensor Medical Technology, LLCaccessdata.fda.gov
December 16, 2014K142715Sensor Medical Family of Vitrectomy Lenses and ProductsHJKSubstantially EquivalentSensor Medical Technology, LLCaccessdata.fda.gov
April 29, 2014K140368FAMILY OF DISPOSABLE LENSESHKSSubstantially EquivalentSensor Medical Technology, LLCaccessdata.fda.gov
November 7, 2007K073010ROYALE AE 9036 LSP INJECTORMSSSubstantially EquivalentAsico, LLCaccessdata.fda.gov
May 2, 2006K053333EAGLEVISION GELLANSERTS, MODEL REF 0040LZUSubstantially EquivalentEagle Vision, Inc.accessdata.fda.gov
March 15, 2006K053622SURGISIS OCULAR GRAFTNXMSubstantially EquivalentIop, Inc.accessdata.fda.gov
July 14, 2003K023737INJECTORMSSSubstantially EquivalentAnton Meyer & Co. , Ltd.accessdata.fda.gov
April 25, 2003K030353MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETSOKSSubstantially EquivalentEagle Vision, Inc.accessdata.fda.gov
July 26, 2002K020882SHARPOINT ULTRAPLUG EXTENDED WEAR PLUGLZUSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
April 20, 1999K991130FLEXPLUGLZUSubstantially EquivalentEagle Vision, Inc.accessdata.fda.gov
May 23, 1994K942194QUANTUM BI-POLAR ELECTROSURGICAL CABLEGEISubstantially EquivalentQuantum Instruments Corp.accessdata.fda.gov
January 31, 1992K912576INSTRUMENT WIPE AND CORNEAL SHIELDHOYSubstantially EquivalentKatena Products, Inc.accessdata.fda.gov
March 28, 1990K897190LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTLZUSubstantially EquivalentLook, Inc.accessdata.fda.gov
February 15, 1990K897034K-SPONGEHOZSubstantially EquivalentKatena Products, Inc.accessdata.fda.gov
April 11, 1989K890920EAGLE VISION-FREEMAN(TM) PUNCTAL VALVELZUSubstantially EquivalentEagle Vision, Inc.accessdata.fda.gov
August 22, 1988K883233EV MONOCANALICULAR STENT (TM)OKSSubstantially EquivalentEagle Vision, Inc.accessdata.fda.gov
March 25, 1982K820526RELIEF VALVE-HONAN INTRAOC. PRESSURELCCSubstantially EquivalentThe Lebanon Corp.accessdata.fda.gov

Compare with other makers

Updated October 13, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.