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510(k) Data Aggregation
K Number
K161372Device Name
The Red Head Collection Device, The Jordy Connection System
Manufacturer
MIAMI FAT SUPPLY
Date Cleared
2017-02-24
(283 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
MIAMI FAT SUPPLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:
- Aspiration of adipose (fatty) tissue
- Harvesting adipose (fatty) tissue
- Filtering adipose (fatty) tissue
- Extraction of autologous adipose (fatty) tissue
Device Description
Device Functions:
- 1. Single Use closed loop system collection device (same)
- 2. Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump.
- 3. Connection system to connect tubing to interfaces
- 4. Funnel to enable fat to separate from fluids
- 5. Channel for fluid evacuation.
- Toomey Syringe to extract fat from device. 6.
Device Design:
- 1. Owner holds patent to predicate device and has improved performance and safety through this design.
- 2. Non-Sterile, Single Use
- 3. Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting.
- 4. Tissue enters canister through collection port on canister lid.
- 5. Funnel perforation large enough for only adipose (fatty) tissue to be collected
- 6. Waste material is removed from canister by closing valve on center of lid.
- 7. Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction.
Physical Properties and Materials Used:
- 1. Canister, Funnel and Outer Lid made from Polycarbonate
- 2. Evacuation spout and pinch clamps made from Polypropylene
- 3. Tubing made from silicone
Intended use of Device:
For use in aspirating subcutaneous fatty tissue including autologous fat collection.
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