FDA device listing
Articulated arm and accessories,Austin Tympanoplasty,Barnhill Adenoid,Bellucci Mic Scissors,Bojrab Dissector,Buck Ear…
FDA device listing 1789545773 · OLYMPUS CORPORATION
Key facts
| Proprietary names | Articulated arm and accessories,Austin Tympanoplasty,Barnhill Adenoid,Bellucci Mic Scissors,Bojrab Dissector,Buck Ear Currette,Chest support,Cottle Septum Speculum,Delacruz measuring,Double Spoon Biopsy Forceps,Joseph Skin Hook,Killian Septum Speculum,Moriyama Univ. Cutt. Fcps,OTRP Trial,Richards,Ritter-Halle Frontal Sinus Dilator,RP Osteotome,Russell-Davis Tongue Bld,Synergry Drill system |
|---|---|
| Owner/operator | OLYMPUS CORPORATION |
| Owner/operator number | 9067818 |
| Product codes | LRC |
| Device names | LRC - Instrument, Ent Manual Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4420 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Gyrus ACMI, Inc., GYRUS ACMI, INC., OLYMPUS WINTER & IBE GMBH |
| Establishment registrations | 1037007, 9610773, 3011050570 |
| FEI numbers | 1037007, 3002807798, 3011050570 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database