2023 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| Blood Bank Control System V6.0 Blood Establishment Computer Software and Accessories |
Blood Bank Control System V6.0 is intended to be used by trained personnel to aid in the collection, manufacture and distribution of blood and blood components. The software is designed to identify eligible donors by the use of both user and donor administered history questionnaire functionality (Computer Assisted Self Interviews (CASI)) along with additional system logic to determine donor eligibility which includes testing as well as donor health screening. The system prevents the release of unsuitable blood and blood components for transfusion or further manufacturing by performing compatibility testing and aids in the manufacture, labeling and shipment of blood and blood products. The system supports the determination of compatibility status of product per patient for transfusion service operations. | BK220790/0 | Blood Bank Computer Systems, Inc. 7206 Vandermark Rd. E Bonney Lake, WA 98391 |
02/17/2023 |
| Procedure Tray - Lipoaspirate fat harvest and injection kit Suction lipoplasty system |
LG PT 15, LG PT 14, LG PT 12, LG PT 04, LG PT 03, LG PT 02 are intended for removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring, within the same procedure. In combination with the Lipogems System these devices are intended for use in the following surgical specialties: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery. | BK220775/0 | Hydra Srl Coronati Consulting Srl Via Luigi Gavioli, 3 I-41037 Mirandola (MO) Italy |
01/04/2023 |