Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff

Name: Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,general-surgery,guidances,industry,notification,pre-market,pre-market-notification,submissions,surgery

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Clinical - Medical, Good Clinical Practice (GCP), Labeling, Premarket

Published

August 15, 2016

Last updated

March 2, 2020

Description

This is a guidance document for the premarket notification of bipolar electrosurgical vessel sealers for general surgery.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff

Updated on March 2, 2020

pdf (450.4KB)

URL: https://www.fda.gov/media/87987/download
Permalink: https://data.openrid.co/en/datasets/r/fce4f85c-7773-4297-96ca-0d6bd71978ab
MIME Type: application/pdf

Created on: August 15, 2016
Modified on: March 2, 2020

Size: 450.4KB

Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

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