NUJ · Class II · 21 CFR 878.4400

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, Renovo, Inc. and Northeast Scientific, Inc. (Nes).

37
Total
37
Cleared
149d
Avg days
2001
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed Devices (Product Code NUJ)

37 devices
1–24 of 37
Cleared Apr 29, 2024
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
K232511
Surgical Instrument Service and Savings, Inc.
General & Plastic Surgery · 255d
Cleared Mar 28, 2023
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K230251
Stryker Sustainability Solutions
General & Plastic Surgery · 57d
Cleared May 13, 2022
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K220411
Stryker Sustainability Solutions
General & Plastic Surgery · 88d
Cleared Apr 07, 2022
Green OR Reprocessed Aquamantys Bipolar Sealer
K211203
Green Or, LLC
General & Plastic Surgery · 350d
Cleared Oct 22, 2019
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
K191073
Vein 360, LLC
General & Plastic Surgery · 183d
Cleared Oct 31, 2018
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
K182588
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
General & Plastic Surgery · 41d
Cleared Apr 23, 2018
Reprocessed LigaSure Maryland Jaw Sealer/Divider
K180499
Stryker Sustainability Solutions
General & Plastic Surgery · 56d
Cleared Apr 20, 2018
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
K180451
Stryker Sustainability Solutions
General & Plastic Surgery · 59d
Cleared Mar 27, 2018
NES Reprocessed RF Stylet (RFS)
K173214
Northeast Scientific, Inc. (Nes)
General & Plastic Surgery · 176d
Cleared Mar 19, 2018
Reprocessed DePuy Mitek Ablation Wand
K173740
Renovo, Inc.
General & Plastic Surgery · 102d
Cleared Mar 05, 2018
Reprocessed ArthoCare Ablation Wand
K173741
Renovo, Inc.
General & Plastic Surgery · 88d
Cleared Feb 21, 2018
Reprocessed ArthroCare ENT Coblator
K172647
Renovo, Inc.
General & Plastic Surgery · 173d

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.