FDA device listing
10cm iQ Broad Knife,11cm iQ Apex Knife,11cm iQ Knife,12cm iQ 120 Claw,12cm iQ Apex 360,12cm iQ Barracuda,12cm iQ…
FDA device listing 1924183303 · STRYKER CORP.
Key facts
| Proprietary names | 10cm iQ Broad Knife,11cm iQ Apex Knife,11cm iQ Knife,12cm iQ 120 Claw,12cm iQ Apex 360,12cm iQ Barracuda,12cm iQ Claw,12cm iQ Large,12cm iQ Micro,12cm iQ Micro Claw,12cm iQ Serrated Large,12cm iQ Standard,18cm iQ Apex Micro Claw,18cm iQ Micro Claw,20cm iQ Apex 360,20cm iQ Standard,SONOPET IQ CONSOLE |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K213824 |
| Product codes | LFL |
| Device names | LFL - Instrument, Ultrasonic Surgical |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.LFL |
| Review panels | General & Plastic Surgery |
| Registered establishments | Stryker Instruments, STRYKER IRELAND LTD., INSTRUMENTS DIVISION, Stryker Ireland Ltd. Instruments Division, Innovation Centre, Stryker Poland Manufacturing Sp. z o.o. |
| Establishment registrations | 9616696, 3015967359, 3031800723, 3040335671 |
| FEI numbers | 3003164255, 3015967359, 3031800723, 3040335671 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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