FDA device listing
Reprocessed HARMONIC ACE+ 7, 5 Mm Diameter Shears With Advanced Hemostasis
FDA device listing 1898301398 · STRYKER CORP.
Key facts
| Proprietary names | Reprocessed HARMONIC ACE+ 7, 5 Mm Diameter Shears With Advanced Hemostasis |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K202554 |
| Product codes | LFL, NLQ |
| Device names | LFL - Instrument, Ultrasonic Surgical, NLQ - Single-Use Reprocessed Ultrasonic Surgical Instruments |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.LFL, ORCA1.NLQ |
| Review panels | General & Plastic Surgery |
| Registered establishments | Stryker Sustainability Solutions, Stryker Sustainability Solutions - Chandler, Stryker Sustainability Solutions Lakeland |
| Establishment registrations | 1056128, 3009350690, 3030153385 |
| FEI numbers | 1000132435, 3009350690, 3030153385 |
| Establishment operations | Reprocessor of Single Use Devices, Specification Developer |
| 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