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510(k) Data Aggregation

    K Number
    K173740
    Device Name
    Reprocessed DePuy Mitek Ablation Wand
    Manufacturer
    ReNovo, Inc.
    Date Cleared
    2018-03-19

    (102 days)

    Product Code
    NUJ, GEI, HRX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ReNovo, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
    Device Description
    Reprocessed DePuy Mitek Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.
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    K Number
    K173741
    Device Name
    Reprocessed ArthoCare Ablation Wand
    Manufacturer
    ReNovo, Inc.
    Date Cleared
    2018-03-05

    (88 days)

    Product Code
    NUJ
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ReNovo, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed ArthroCare Ablation Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
    Device Description
    Reprocessed ArthroCare Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.
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    K Number
    K172647
    Device Name
    Reprocessed ArthroCare ENT Coblator
    Manufacturer
    ReNovo, Inc.
    Date Cleared
    2018-02-21

    (173 days)

    Product Code
    NUJ
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ReNovo, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed ArthroCare ENT Coblators are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: - Adenoidectomy - Cysts - Head, Neck, Oral, and Sinus Surgery - Mastoidectomy - Myringotomy with Effective Hemorrhage Control - Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates - Nasopharyngeal/Laryngeal indications including Tracheal Procedures, - Laryngeal Polypectomy, and Laryngeal Lesion Debulking - Neck Mass - Papilloma Keloids - Submucosal Palatal Shrinkage - Submucosal Tissue Shrinkage - Tonsillectomy (including palatine tonsils) - Traditional Uvulopalatoplasty (RAUP) - Tumors - Tissue in the Uvula/Soft Palate for the Treatment of Snoring
    Device Description
    Reprocessed ENT Coblators are radiofrequency (RF) surgical devices which are powered by an RF generator. The device is designed for the hemostasis of blood vessels, dissection, and removal of tissue during otorhinolaryngology ( ENT) surgical procedures. ENT probes vary in their configuration depending on intended usage in their diameter, length, electrode shape, and saline delivery/suction capabilities. The materials of constructions are generally polycarbonate handles, stainless steel shafts, Polyester or Tygon insulation material, tungsten electrodes, alumina ceramic tips and PVC saline delivery/suction tubing lines
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    K Number
    K172097
    Device Name
    Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
    Manufacturer
    Renovo, Inc.
    Date Cleared
    2017-10-06

    (87 days)

    Product Code
    NLM
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renovo, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions. The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
    Device Description
    A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the port, and; the obturator which is a mechanism that allows the cannula to penetrate the abdomen. The trocars contained in this submission are bladeless. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.
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    K Number
    K172093
    Device Name
    Reprocessed Covidien Trocar
    Manufacturer
    Renovo, Inc.
    Date Cleared
    2017-10-05

    (86 days)

    Product Code
    NLM
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renovo, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed Covidien Trocars are indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
    Device Description
    A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.
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    K Number
    K172092
    Device Name
    Reprocessed Shavers/Burs
    Manufacturer
    Renovo, Inc.
    Date Cleared
    2017-10-04

    (85 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renovo, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures. The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power II Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure. The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints: Knee Shoulder Ankle Elbow Wrist Hip Temporamandibular The Reprocessed Styker Shavers and Burs will be used to resect tissue and bur bone. Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
    Device Description
    The Reprocessed Shavers and Burs are intended to be used for arthroscopic and laparoscopic surgical techniques. Shavers have sharp rotating inner blades housed in an outer shaft designed to cut tissue. Burs have an abrasive wearing surface that rotate in an outer sheath to grind down bone. The housing has a window cut out on one side of the distal end, allowing the bur to cut one part of the intended anatomy, while the adjacent one is still protected by the housing on the opposite side of the abrader, bur or blade. There are various configurations of diameter, length, and cutting or grinding surfaces. The materials of construction are generally: metal shafts, lubricants (between the inner and outer components to reduce friction and heat), and polymer hubs bonded to the shafts. The polymer hub connects to a user-supplied motorized hand piece, which drives the internal abrader, bur or blade inside the outer housing. The handpiece provides suction to remove tissue which has been cut during the surgical procedure. There are 39 Stryker shavers and 33 Stryker burs included in this submission. The Stryker shavers and burs are used with the Total Performance System Shaver handpiece is made of a motor housing with a coupling mechanism to secure the shavers/burs to the handpiece. There are 31 Smith & Nephew shavers and 32 Smith & Nephew burs included in this submission. The Smith & Nephew shavers and burs are intended to be used with the Smith & Nephew DYONICS Power II Shaver System control unit. This system is compatible with DYONICS POWER handpieces. There are 94 ConMed/Linvatec shavers and 26 ConMed/Linvatec burs included in this submission. The Linvatec shavers and burs are intended to be used with the Linvatec Integrated Drive/Pump system. The system has three different handpieces that ca be used for otolaryngology, neurological surgical, orthopedic, and spinal procedures.
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