Stephens Instruments, Inc
Lexington, KY, US
STEPHENS INSTRUMENTS, INC appears in FDA device records in Lexington, KY. FDA records list 5 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Stephens Instruments, Inc in 2002.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | HRH | Substantially Equivalent | |
| K022842 | STEPHENS DISPOSABLE HOOKS | HNQ | Substantially Equivalent | |
| K022840 | STEPHENS DISPOSABLE SCISSORS | HNF | Substantially Equivalent | |
| K022836 | STEPHENS DISPOSABLE SPECULUM | HNC | Substantially Equivalent | |
| K022835 | STEPHENS DISPOSABLE FORCEPS | HNR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1045379 | 1045379 | STEPHENS INSTRUMENTS, INC | 2500 Sandersville Rd, LEXINGTON, KY 40511 US | 2026 | and 43 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal
- HOGBurr, Corneal, Battery-Powered
- HOFBurr, Corneal, Manual
- HOECaliper, Ophthalmic
- HMXCannula, Ophthalmic
- HODClamp, Eyelid, Ophthalmic
- HOBClamp, Muscle, Ophthalmic
- HOCClip, Iris Retractor
- HPBClip, Lens, Trial, Ophthalmic
- HQWClip, Tantalum, Ophthalmic
- FMHContainer, Specimen, Sterile
- HNZCurette, Ophthalmic
- HNYCystotome
- HNXDepressor, Orbital
- HNWDilator, Lachrymal
- GDIDissector, Surgical, General & Plastic Surgery
- HNSExpressor
- HQHEye, Artificial, Non-Custom
- HTDForceps
- HNRForceps, Ophthalmic
- HPAFrame, Trial, Ophthalmic
- HLNGauge, Lens, Ophthalmic
- PPMGeneral Purpose Reagent
- GDZHandle, Scalpel
- FHQHolder, Needle, Gastroenterologic
- HXKHolder, Needle; Orthopedic
- HNQHook, Ophthalmic
- HJBInstrument, Measuring, Corneal Radius
- HNNKnife, Ophthalmic
- HKRLens, Maddox
- HJFMagnifier, Hand-Held, Low-Vision
- HMRMarker, Ocular
- HMQMarker, Sclera
- GDMNeedle, Aspiration And Injection, Reusable
- LZUPlug, Punctum
- HNLProbe, Lachrymal
- HNKProbe, Trabeculotomy
- HNJPunch, Corneo-Scleral
- HNIRetractor, Ophthalmic
- HNHRing, Ophthalmic (Flieringa)
- HNGRongeur, Lachrymal Sac
- HLERuler, Nearpoint (Punctometer)
- HNFScissors, Ophthalmic
- HPCSet, Lens, Trial, Ophthalmic
- HNDSpatula, Ophthalmic
- HNCSpecula, Ophthalmic
- HNBSpoon, Ophthalmic
- HNASpud, Ophthalmic
- HMZTrabeculotome
- FSMTray, Surgical, Instrument
- HRHTrephine, Manual, Ophthalmic
- LGYTrypan Blue
- ECBUnit, Syringe, Air And/Or Water
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain