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 Sterilmed, Inc., Stryker Sustainability Solutions and Surgical Instrument Service and Savings, Inc..

37
Total
37
Cleared
149d
Avg days
2001
Since
37 devices
25–37 of 37
Cleared Jan 25, 2013
REPROCESSED VESSEL SEALER
K123096
Sterilmed, Inc.
General & Plastic Surgery · 115d
Cleared Oct 05, 2012
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
K120040
Sterilmed, Inc.
General & Plastic Surgery · 274d
Cleared Aug 16, 2012
RESPROCESSED SERFAS ENERGY PROBE
K121855
Stryker Sustainability Solutions
General & Plastic Surgery · 52d
Cleared Nov 15, 2011
REPROCESSED HAND ACTIVATE SEALER/DIVIDER
K111600
Ascent Healthcare Solutions
General & Plastic Surgery · 160d
Cleared Jul 18, 2011
REPROCESSED ELECTROSURGICAL INSTRUMENT
K110189
Ascent Healthcare Solutions
General & Plastic Surgery · 175d
Cleared Jul 21, 2010
NES REPROCESSED VARICOSE VEIN RF CATHETER
K090661
Northeast Scientific, Inc.
General & Plastic Surgery · 496d
Cleared Feb 12, 2008
REPROCESSED SCISSOR TIPS
K073613
Sterilmed, Inc.
General & Plastic Surgery · 53d
Cleared May 12, 2006
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
K052690
Suretek Medical
General & Plastic Surgery · 226d
Cleared May 10, 2006
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
K052692
Suretek Medical
General & Plastic Surgery · 224d
Cleared May 10, 2006
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
K052695
Suretek Medical
General & Plastic Surgery · 224d
Cleared May 27, 2005
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K043198
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 190d
Cleared Nov 07, 2001
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
K012598
Sterilmed, Inc.
General & Plastic Surgery · 89d
Cleared Nov 07, 2001
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012603
Alliance Medical Corp.
General & Plastic Surgery · 86d