FDA device listing
Focused Bipolar Forceps,Focused Irrigating Bipolar Forceps,Illuminated Bipolar Forceps,Irrigating Bipolar…
FDA device listing 1325113870 · Katalyst Surgical, LLC
Key facts
| Proprietary names | Focused Bipolar Forceps,Focused Irrigating Bipolar Forceps,Illuminated Bipolar Forceps,Irrigating Bipolar Forceps,Strandard Bipolar Forceps |
|---|---|
| Owner/operator | Katalyst Surgical, LLC |
| Owner/operator number | 10029103 |
| Premarket submissions | K123172 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | KATALYST SURGICAL, LLC |
| Establishment registrations | 3007589150 |
| FEI numbers | 3007589150 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer, Remanufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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