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510(k) Data Aggregation
K Number
K181173Device Name
ELMED Laparoscopic Instruments and Accessories
Manufacturer
Date Cleared
2019-03-22
(324 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ELMED Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue.
The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by use of high frequency electric current.
Manually operated surgical instruments are available with or without monopolar high frequency connection and are designed to be used through an opening maintained by a cannula which allows inserting and removal of the instrument(s) without damaging the tissue(s).
Bipolar Forceps are designed to grasp, manipulate and coagulate selected soft tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator.
Suction/ Irrigation Cannulas have an application(s) in laparoscopic procedures such as gynecologic, general, thoracic and urology and are intended to provide suction and irrigation to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Trocars and Trocar Sleeves are intended to create portals into an operative site for the direct visualization and/or inserting of other surgical instruments.
Needle holders are intended to grasp and manipulate needles inside the peritoneal cavity enabling a surgeon to suture internal soft tissue during a laparoscopic procedure.
Instruments should be used only by personnel completely familiar with their operation.
Device Description
These devices represent a family of Laparoscopic/Endoscopic Instruments and Accessories that consist of:
- . Laparoscopic Monopolar electrodes
- . Laparoscopic Bipolar forceps
- Laparoscopic Trocars, Trocar sleeves
- . Laparoscopic Needle Holders
- . Laparoscopic Suction/ Irrigation Cannulas
- . Laparoscopic Suture and Ligature Instruments
- . Laparoscopic various manually operated surgical instruments with and without monopolar high frequency connection ( scissors, graspers/dissectors, biopsy forceps)
- . Laparoscopic Accessories such as: Cleaning Brushes, Sealing Caps, Adapters
Various configurations, sizes and handles of the jaws (graspers, forceps, scissors, dissectors, biopsy, and punches) exist to meet the needs of surgical procedures in conjunction with a laparoscope/endoscope. The instruments have the capability for monopolar RF current, if needed. These instruments are composed of biocompatible materials (surgical grade stainless steel, PTFE, PEEK, several coatings, silicon and brass chromium plated). These materials have a long history of biocompatibility for human use at short term contact. The instruments are reusable and sold non-sterile.
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