FDA device listing
Adenoid forceps,Biopsy forceps,Clip applier,Cotton applicator,Dressing forceps,Ear forceps,Gelfoam pressure…
FDA device listing 1009080247 · OLYMPUS CORPORATION
Key facts
| Proprietary names | Adenoid forceps,Biopsy forceps,Clip applier,Cotton applicator,Dressing forceps,Ear forceps,Gelfoam pressure forceps,Grasping forceps,Laryngeal forceps,Nasal forceps,Needle holder,Pharyngeal forceps,Punch forceps,Septum forceps,Swab forceps,Thumb forceps,Tonsil forceps,Towel forceps,Turbinate forceps |
|---|---|
| Owner/operator | OLYMPUS CORPORATION |
| Owner/operator number | 9067818 |
| Product codes | HTD |
| Device names | HTD - Forceps |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Gyrus ACMI, Inc., OLYMPUS WINTER & IBE GMBH |
| Establishment registrations | 9610773, 3011050570 |
| FEI numbers | 3002807798, 3011050570 |
| Establishment operations | Complaint File Establishment, Foreign Exporter |
| 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