Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1045379

FEI Number

1045379

Entity Name

STEPHENS INSTRUMENTS, INC

City/State/Country

LEXINGTON, KY, US

Establishment Address

2500 Sandersville Rd, LEXINGTON, KY 40511, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STEPHENS INSTRUMENTS, INC. (Owner Number: 1045379)

Owner / Operator Contact Address

2500 SANDERSVILLE RD., --, Lexington, KY 40511, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ophthalmic Spatula Dissector C-BLUE Cystotome Lacrivera Stephens Scissors Needle Holder Ocular Marker Corneal radius measurement instrument Muscle Clamp Ophthalmic Retractor Stephens Forceps Curette Sclera Marker Stephens Trephine Ophthalmic Gauge Ophthalmic Burr Scalpel Eyelid clamp Trabeculotome Ophthalmic Probe Vera90 Cannula Stephens Glass Cannula Clip Stephens Hook Stephens Speculum Caliper Ruler Aspiration Needle Scleral Punch Stephens Instruments Fixation Ring Probe, Lachrymal Xpand Stephens Microsurgical Blades Dilator Magnifier PV Iodine Maddox Stephens Corneal Viewing Chamber

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-08-15
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-06-03
LGY	Trypan Blue	Hematology	Class 1	864.1850	2016-03-30
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2016-08-15
LZU	Plug, Punctum	Unknown	Class U	N/A	2014-12-01
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-05
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2017-07-28
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2026-06-03
HJB	Instrument, Measuring, Corneal Radius	Ophthalmic	Class 1	886.1450	2026-06-03
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-08-15
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-08-15
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-05
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-08-15
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2016-08-15
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-05
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2016-08-15
HOF	Burr, Corneal, Manual	Ophthalmic	Class 1	886.4350	2016-08-15
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-06-03
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-03
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2016-08-16
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2016-08-16
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-06-21
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-08-12
HPB	Clip, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1410	2016-08-15
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-05
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-05
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-07-28
HLE	Ruler, Nearpoint (Punctometer)	Ophthalmic	Class 1	886.1790	2016-08-15
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2026-06-03
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2016-08-15
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2020-09-17
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2022-03-25
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2013-12-12
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-05
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2016-08-16
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2016-08-15
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2011-06-21
HKR	Lens, Maddox	Ophthalmic	Class 1	886.1400	2016-08-15
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2012-06-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STEPHENS INSTRUMENTS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008808084	F.A. Najmmy Industries	Sialkot Punjab, PK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1045379. Last updated year: 2026. Please use registration number 1045379 when referencing this establishment in official correspondence.