Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Finalizes Class II Status For Surgical Staplers

Executive Summary

The US agency reclassified the device from low-risk class I to moderate-risk class II after reviewing tens of thousands of adverse event reports.

You may also be interested in...



Panel Backs FDA’s Suggestion Of Class II Stapler Status

A US FDA panel unanimously agreed that surgical staplers should be reclassified into class II on 30 May, backing FDA recommendations.

It’s A Class I Recall For Baxter’s WatchCare Device

Radiofrequencies from the incontinence-sensing devices may interfere with other medical equipment in a hospital setting. 

It’s A Class I Recall For Baxter’s WatchCare Device

Radiofrequencies from the incontinence-sensing devices may interfere with other medical equipment in a hospital setting. 

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT144556

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel