BEUDAMED
    Product Code: NUJ FDA class 2 21 CFR 878.4400

    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

    General, Plastic Surgery

    The Reprocessed Electrosurgical Cutting and Coagulation Accessories for Laparoscopic and Endoscopic Use are single-use electrosurgical instruments that have been reprocessed for reuse in laparoscopic and endoscopic surgical procedures. Reprocessing validation data must be included in the 510(k) submission for this device type per FDA guidance published at 70 FR 56911. It is an FDA Class 2 device regulated under 21 CFR 878.4400 in the General and Plastic Surgery specialty, with product code NUJ, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.

    View on FDA
    510(k)s
    37
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    20
    Years Active
    22

    Basic Information

    Product Code
    NUJ
    Device Class
    FDA class 2
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 37 510(k) clearances via K numbers.

    K Number Device Name
    K232511 Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
    K230251 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
    K220411 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
    K211203 Green OR Reprocessed Aquamantys Bipolar Sealer
    K191073 Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
    K182588 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
    K180499 Reprocessed LigaSure Maryland Jaw Sealer/Divider
    K180451 Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
    K173214 NES Reprocessed RF Stylet (RFS)
    K173740 Reprocessed DePuy Mitek Ablation Wand
    K173741 Reprocessed ArthoCare Ablation Wand
    K172647 Reprocessed ArthroCare ENT Coblator
    K172608 Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
    K171324 Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
    K162751 Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    K161086 Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
    K160333 Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
    K153745 Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
    K152134 Reprocessed Vessel Sealer
    K152313 Medline ReNewal Reprocessed Endopath Endoscopic Instruments
    K150538 Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
    K143260 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
    K133578 REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
    K131614 REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
    K123096 REPROCESSED VESSEL SEALER
    K120040 REPROCESSED SURGICAL ELECTRIC INSTRUMENT
    K121855 RESPROCESSED SERFAS ENERGY PROBE
    K111600 REPROCESSED HAND ACTIVATE SEALER/DIVIDER
    K110189 REPROCESSED ELECTROSURGICAL INSTRUMENT
    K090661 NES REPROCESSED VARICOSE VEIN RF CATHETER
    K073613 REPROCESSED SCISSOR TIPS
    K052690 SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
    K052695 SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
    K052692 SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
    K043198 VANGUARD REPROCESSED ARTHROSCOPIC WANDS
    K012603 REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
    K012598 REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.