Requests that the FDA take steps to refine and reinforce a foundational aspect of 510(k) regulation of surgical stapling products | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-6523

Requests that the FDA take steps to refine and reinforce a foundational aspect of 510(k) regulation of surgical stapling products

Documents

Comments

Description

Open

Key Dates

Comment Period OpensNov 28, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgement Letter from FDA DMB to Chul-Hi Park	Nov 28, 2025	--

Comment Statistics

Total Comments

Keywords

CDRH

Citizen Petition

Requests that the FDA take steps to refine and

reinforce a foundational aspect of

510(k) regulation of surgical stapling products

Open

Data from Regulations.gov