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510(k) Data Aggregation
K Number
K081398Device Name
ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
Manufacturer
Date Cleared
2009-02-06
(263 days)
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Advanced Medical Monopolar Scissors, Maryland Dissecting Forceps, Lap Clinch, Rat Tooth LapClinch, Babcock, Straight Grasping Forceps with Ratchet are indicated for use in gynecological and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators.
The Advanced Medical Reducer has application in gynecologic laparoscopy and other abdominal procedures and is designed to be used with the Advanced Medical Disposable Surgical Trocar to allow the surgeon to insert undersized instruments through the Trocar without losing insufflation.
The Advanced Medical Laparoscopic Smoke Filter is intended for the filtration of contaminants from smoke, generated during laparoscopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria and viruses).
The Advanced Medical Hasson Trocar and Dilating Tip Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Advanced Medical Shielded Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.
The Advanced Medical Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).
The Secondary Trocar is used in endoscopic surgery (abdominal and thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laparoscopes and probes. There is a seal on the cap which closes the port of entry.
The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.
The Advanced Medical Suction/Irrigation Set is intended for use in endoscopic procedures such as laparoscopy, pelviscopy, and thorascopy, for suctioning of large clots, retrieving spilled stones, high flow irrigation and hydro-dissection.
Device Description
The Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and surgical procedures) to cut, dissect, manipulate and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories.
The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated gamma procedure per AAMI/ISO International standard 11137 (EN 552) to a SAL of 10-6.
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