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FDA Finalizes Class II Status For Surgical Staplers

 
• By Elizabeth Orr

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.

skin-stapler

Surgical staplers for internal use will face stricter regulatory requirements in the US under a Food and Drug Administration final order moving the products from low-risk class I to moderate-risk class II.

A final guidance document on surgical stapler labeling and an updated letter to health care providers about the products were issued alongside the 7 October order.

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