FDA device listing
ENSEAL 1X Tissue Sealer, Curved Jaw, Articulating
FDA device listing 1874589446 · ETHICON ENDO-SURGERY, INC.
Key facts
| Proprietary names | ENSEAL 1X Tissue Sealer, Curved Jaw, Articulating |
|---|---|
| Owner/operator | ETHICON ENDO-SURGERY, INC. |
| Owner/operator number | 9010225 |
| Premarket submissions | K180403 |
| Product codes | GEI, HGI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories, HGI - Electrocautery, Gynecologic (And Accessories) |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400, 884.4120 |
| Review panels | General & Plastic Surgery, Obstetrics/Gynecology |
| Registered establishments | ETHICON ENDO-SURGERY, INC., ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II |
| Establishment registrations | 1527736, 9710649 |
| FEI numbers | 1527736, 3003565435 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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