Strykerware System
FDA 510(k) K024159 · Stryker Endoscopy
510(k) numberK024159
Submission
- Device name
- Strykerware System
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- December 17, 2002
- Decision date
- March 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Strykerware System cleared by the FDA?
Strykerware System (K024159) received a 510(k) decision of Substantially Equivalent on March 10, 2003, 83 days after the submission was received.
What is the product code of K024159?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.