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510(k) Data Aggregation
K Number
K101193Device Name
PMC LAPAROSCOPIC INSTRUMENTS
Manufacturer
PMC MEDICAL GMBH
Date Cleared
2010-10-18
(173 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PMC MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.
Device Description
PMC Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures as:
-unexplained pelvic pain (acute, chronic)
-infertility work-up
-tubal sterilization
-diagnosis and/or treatment of ectopic pregnancy
-evaluation, diagnosis and/or treatment of pelvic tumors, incl. myomata (less than 16 weeks gestational size)
-Retrieval of foreign bodies
-determination of the presence and extent of pelvic endometriosis
-determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
-access to abdomen for surgical procedures such as LAVH
-visualization, diagnosis and/or treatment of perforate abdominal organs
The PMC Laparoscopic instruments contain different components such as scissors, forceps, connections, handles, sheaths, laparoscopes, light adapters, trocars, electrode, and inserts. The instruments are made out of martensitic stainless steel, a standard material for medical devices, and insulation material.
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