FDA device listing
SmartBand Ligation Kit (EN-MF, IE-SD),SmartBand Ligation Pack (EN-MF, IE-SD),SmartBand SafeGrip Multi-Band Ligation Kit…
FDA device listing 1528135438 · STERIS Corporation
Key facts
| Proprietary names | SmartBand Ligation Kit (EN-MF, IE-SD),SmartBand Ligation Pack (EN-MF, IE-SD),SmartBand SafeGrip Multi-Band Ligation Kit (EN-MF, IE-SD),SmartBand SafeGrip Multi-Band Ligation Pack (EN-MF, IE-SD) |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Product codes | FHN |
| Device names | FHN - Ligator, Hemorrhoidal |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.4400 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | UNITED STATES ENDOSCOPY GROUP, INC. |
| Establishment registrations | 1528319 |
| FEI numbers | 1000122656 |
| Establishment operations | Manufacturer |
| 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