Identifiers
- 510(k) Number
- K024159 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The StrykerWare System is a medical imaging and connectivity platform designed for use in endoscopic procedures. It integrates advanced visualization technology with operating room connectivity to support minimally invasive surgical techniques across multiple specialties.
This system is supplied as a reusable device and is intended for use in clinical settings where real-time imaging and data management are required. It is regulated under FDA 510(k) clearance (K024159) and is classified under the product code LLZ, with a decision of Substantially Equivalent by the Radiology Advisory Committee. No sterility or single-use designation is specified.
Frequently asked questions
Is the StrykerWare System designed for single-use or can it be reused in multiple procedures?
The StrykerWare System is explicitly supplied as a reusable device, meaning it is intended for repeated use across multiple endoscopic procedures in clinical settings. There is no mention of single-use or sterility requirements in the provided data, so proper cleaning and maintenance protocols would apply for reuse.
What specialties or surgical techniques does the StrykerWare System support, and how does it enhance the procedure?
The system is designed to support minimally invasive surgical techniques across multiple specialties by integrating advanced visualization technology with operating room connectivity. It provides real-time imaging and data management, which improves precision and workflow efficiency during endoscopic procedures.
How is the StrykerWare System regulated, and what does its classification under product code LLZ indicate?
The StrykerWare System holds FDA 510(k) clearance (K024159) and is classified under product code LLZ, which falls under the Radiology category. The decision was made by the Radiology Advisory Committee (RA) and determined to be *Substantially Equivalent* to a predicate device, meaning it meets regulatory standards for imaging-related functionality without requiring a new clinical trial.
Who should I contact for technical or support inquiries about the StrykerWare System?
For inquiries, you may reach out to Evan Norton at Stryker Endoscopy, whose contact details are listed as part of the FDA submission. The address provided is 5900 Optical Ct., San Jose, CA 95138, US, though direct contact methods (e.g., phone/email) would need to be verified through official Stryker channels.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Endoscopy | Stryker, Endoscopy - Stryker, Stryker Endoscopy 1088 Operating And Maintenance Manual, Endoscopy - IFUs : Stryker, STRYKER ENDOSCOPY STANDARD SERVICE MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K024159 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K024159 24 fields · synced Sep 19, 2026