FDA Product Code NUJ: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
FDA product code NUJ covers reprocessed electrosurgical cutting and coagulation accessories cleared after validated reprocessing cycles.
Electrosurgical accessories — including pencils, electrodes, and return pads — are reprocessed to provide a cost-effective alternative to single-use devices that meets the same safety, sterility, and functional performance standards as the original device.
NUJ devices are Class II medical devices, regulated under 21 CFR 878.4400 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Stryker Sustainability Solutions and Surgical Instrument Service and Savings, Inc..
FDA 510(k) Cleared Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed Devices (Product Code NUJ)
About Product Code NUJ - Regulatory Context
510(k) Submission Activity
37 total 510(k) submissions under product code NUJ since 2001, with 37 receiving FDA clearance (average review time: 149 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
NUJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →