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510(k) Data Aggregation
K Number
K212786Device Name
LevaLap Laparoscopic Access Device
Manufacturer
Date Cleared
2022-02-23
(175 days)
Product Code
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Core Access Surgical Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.
Device Description
The LevaLap Laparoscopic Access Device is a sterile single-use device, consisting of a clear hemisphere-shaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access. The device includes a vacuum bypass plug positioned in the vacuum intake port.
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