FDA device listing
Interi Manifold,Interi System,Interi Therapy Unit
FDA device listing 1670582470 · IC Surgical Inc
Key facts
| Proprietary names | Interi Manifold,Interi System,Interi Therapy Unit |
|---|---|
| Owner/operator | IC Surgical Inc |
| Owner/operator number | 10076158 |
| Product codes | GCY |
| Device names | GCY - Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4680 |
| Review panels | General & Plastic Surgery |
| Registered establishments | IC SURGICAL INC |
| Establishment registrations | 3017101761 |
| FEI numbers | 3017101761 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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