Ethicon, Inc. - FDA 510(k) Cleared Devices

Ethicon, Inc. is a subsidiary of Johnson & Johnson specializing in surgical sutures and wound closure devices. The company is headquartered in Raritan, United States.

Ethicon has received 195 FDA 510(k) clearances from 202 total submissions since 1976. The company's regulatory focus centers on General & Plastic Surgery devices, which represent the majority of its cleared submissions. The latest FDA 510(k) clearance was granted in 2026, demonstrating continued regulatory activity.

Ethicon has manufactured surgical sutures and wound closure technologies since 1887. The company holds approximately 80% market share in surgical sutures within the United States and operates in 52 countries globally. Core product categories include absorbable and non-absorbable sutures, knotless tissue control devices, skin closure systems, and continence devices for urological applications.

Explore the complete regulatory record by reviewing individual device names, product codes, and FDA 510(k) clearance dates in the database.