Coloplast A/S - FDA 510(k) Cleared Devices

Coloplast A/S, is a Danish multinational medical device manufacturer based in McHenry, US. The company develops and markets devices for ostomy, urology, continence, and wound care.

Coloplast has received 69 FDA 510(k) clearances from 72 total submissions since its first clearance in 1983. The company's regulatory portfolio is dominated by Gastroenterology & Urology devices, including catheter systems, guidewires, and access sheaths. The latest clearance on record dates to 2023, reflecting the company's historical engagement with FDA regulatory pathways.

Notable cleared devices include the SpeediCath Compact catheter line, Peristeen Anal Irrigation System, and Orchestra Hydrophilic Guidewire variants. The company has also cleared devices in obstetrics, gynecology, and general surgery, demonstrating breadth across multiple specialties.

Explore the complete regulatory record, including device names, product codes, and clearance dates, to review Coloplast's FDA 510(k) submission history.

510(k) submissions have been managed by Coloplast A.S. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.