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Data / Medical devices / United States / Stephens Instruments, Inc

Stephens Instruments, Inc: FDA-registered device maker in Lexington, KY, United States, 4 510(k) clearances

Stephens Instruments, Inc is registered with the FDA (registration 1045379) in Lexington, KY, United States. It lists 53 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 28, 2015. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Stephens Instruments, Inc
FDA registration number
1045379
Address
2500 Sandersville Rd, Lexington, KY, United States, 40511
Owner or operator
STEPHENS INSTRUMENTS, INC. (1045379)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer
First device listed
January 5, 2011
Registered through
2027
Brand names listed
Artificial Eye, Aspiration Needle, C-BLUE, Caliper, Cannula, Clip, Clip, Tantalum, Ophthalmic, Corneal Burr, rust ring removal and more

Devices it lists

DeviceProduct codeClassRoleSource
Burr, Corneal, Battery Powered, Rust Ring RemovalOHW1Repackager or relabeleraccessdata.fda.gov
Burr, Corneal, Battery-PoweredHOG1Repackager or relabeleraccessdata.fda.gov
Burr, Corneal, ManualHOF1Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Complaint file establishment, Manufactureraccessdata.fda.gov
Cannula, OphthalmicHMX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, Eyelid, OphthalmicHOD1Repackager or relabeleraccessdata.fda.gov
Clamp, Muscle, OphthalmicHOB1Repackager or relabeleraccessdata.fda.gov
Clip, Iris RetractorHOC1Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Clip, Lens, Trial, OphthalmicHPB1Repackager or relabeleraccessdata.fda.gov
Clip, Tantalum, OphthalmicHQW2Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Curette, OphthalmicHNZ1Repackager or relabeleraccessdata.fda.gov
CystotomeHNY1Repackager or relabeleraccessdata.fda.gov
Depressor, OrbitalHNX1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
ExpressorHNS1Repackager or relabeleraccessdata.fda.gov
Eye, Artificial, Non-CustomHQH1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Frame, Trial, OphthalmicHPA1Repackager or relabeleraccessdata.fda.gov
Gauge, Lens, OphthalmicHLN1Repackager or relabeleraccessdata.fda.gov
General Purpose ReagentPPM1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Complaint file establishment, Manufactureraccessdata.fda.gov
Hook, OphthalmicHNQ1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Instrument, Measuring, Corneal RadiusHJB1Repackager or relabeleraccessdata.fda.gov
Knife, OphthalmicHNN1Repackager or relabeleraccessdata.fda.gov
Lens, MaddoxHKR1Repackager or relabeleraccessdata.fda.gov
Magnifier, Hand-Held, Low-VisionHJF1Repackager or relabeleraccessdata.fda.gov
Marker, OcularHMR1Repackager or relabeleraccessdata.fda.gov
Marker, ScleraHMQ1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Plug, PunctumLZUUManufacturer, Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Probe, TrabeculotomyHNK1Repackager or relabeleraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Repackager or relabeleraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Repackager or relabeleraccessdata.fda.gov
Rongeur, Lachrymal SacHNG1Repackager or relabeleraccessdata.fda.gov
Ruler, Nearpoint (Punctometer)HLE1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Set, Lens, Trial, OphthalmicHPC1Repackager or relabeleraccessdata.fda.gov
Spatula, OphthalmicHND1Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Spoon, OphthalmicHNB1Repackager or relabeleraccessdata.fda.gov
Spud, OphthalmicHNA1Repackager or relabeleraccessdata.fda.gov
TrabeculotomeHMZ1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Repackager or relabeler, Reprocessoraccessdata.fda.gov
Trypan BlueLGY1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.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
August 28, 2015K150288PDO Absorbable Punctum PlugLZUSubstantially EquivalentRiverpoint Medicalaccessdata.fda.gov
November 13, 2014K140352VERAPLUGLZUSubstantially EquivalentKrishna Imports Inc Dba Stephens Instrumentsaccessdata.fda.gov
July 26, 2002K020882SHARPOINT ULTRAPLUG EXTENDED WEAR PLUGLZUSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
March 28, 1990K897190LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTLZUSubstantially EquivalentLook, Inc.accessdata.fda.gov

Compare with other makers

Updated August 28, 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.