FDA device listing
CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA
FDA device listing 2016034898 · Integra LifeSciences Corporation
Key facts
| Proprietary names | CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| Premarket submissions | K161882 |
| 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 Canada ULC, Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, INTEGRA LIFESCIENCES (IRELAND) LIMITED, INTEGRA NEUROSCIENCES, Integra Pain Management |
| Establishment registrations | 1722447, 2648988, 3003418325, 3004608878, 3006697299, 3012507533 |
| FEI numbers | 1000138491, 3000204775, 3003418325, 3004608878, 3006697299, 3012507533 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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