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510(k) Data Aggregation
K Number
K120902Device Name
GID 700
Manufacturer
THE GID GROUP, INC.
Date Cleared
2012-08-15
(142 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
THE GID GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GID 700 is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
The GID 700 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
Device Description
The GID Group's GID 700 device is a sterile, single use 700 ml canister and accessories used to receive and filter tissue from lipoplasty procedures. When the tissue is deposited into the canister, it is filtered through a mesh filter to capture the tissue. The vacuum source is user or institution supplied. Various ports on the canister provide access to the vacuum source, receives the harvested tissue, vent the canister during the wash process, and transfer the filtered tissue.
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