Stryker Navigation System - ENT Module
FDA 510(k) K002732 · Stryker Corp.
510(k) numberK002732
Submission
- Device name
- Stryker Navigation System - ENT Module
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- September 1, 2000
- Decision date
- October 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stryker Navigation System - ENT Module cleared by the FDA?
Stryker Navigation System - ENT Module (K002732) received a 510(k) decision of Substantially Equivalent on October 2, 2000, 31 days after the submission was received.
What is the product code of K002732?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.