Stryker RF Multi-Lesion Generator, Model 0406-900-000
FDA 510(k) K071482 · Synergetics, Inc.
510(k) numberK071482
Submission
- Device name
- Stryker RF Multi-Lesion Generator, Model 0406-900-000
- Applicant
- Synergetics, Inc.
O' Fallon, MO, US - Received
- May 30, 2007
- Decision date
- December 20, 2007
- 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 RF Multi-Lesion Generator, Model 0406-900-000 cleared by the FDA?
Stryker RF Multi-Lesion Generator, Model 0406-900-000 (K071482) received a 510(k) decision of Substantially Equivalent on December 20, 2007, 204 days after the submission was received.
What is the product code of K071482?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.