FDA device listing
CUSA® Clarity 23 kHz Extended Laparoscopic Tip,CUSA® Clarity 23 kHz Standard Laparoscopic Tip
FDA device listing 1942806843 · Integra LifeSciences Corporation
Key facts
| Proprietary names | CUSA® Clarity 23 kHz Extended Laparoscopic Tip,CUSA® Clarity 23 kHz Standard Laparoscopic Tip |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| Premarket submissions | K221763 |
| Product codes | LBK, LFL |
| Device names | LBK - Neurosurgical Ultrasonic Instruments, LFL - Instrument, Ultrasonic Surgical |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.LBK, ORCA1.LFL |
| Review panels | General & Plastic Surgery, Neurology |
| Registered establishments | Integra LifeSciences Corporation, INTEGRA LIFESCIENCES (IRELAND) LIMITED, INTEGRA NEUROSCIENCES |
| Establishment registrations | 2648988, 3003418325, 3006697299 |
| FEI numbers | 3000204775, 3003418325, 3006697299 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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