Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 9, 2020
March 9, 2020
92e6b261-3141-4df1-ae3c-32bb9fcfbfb3
Related Documents
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentFebruary 21, 2023Center for Devices and Radiological Health
Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentMay 20, 2021Center for Devices and Radiological Health
Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 28, 2022Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox