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The Progenikine Concentrating System is used in medical procedures involving the harvesting of autologous adipose tissue. The Progenikine® Concentrating System is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Progenikine Concentrating System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.

Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.

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This document is a 510(k) clearance letter for a medical device (Progenikine Concentrating System). It does not contain any information about acceptance criteria, device performance data, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), MRMC studies, or standalone algorithm performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It primarily addresses regulatory aspects such as registration, listing, labeling, manufacturing practices, and adverse event reporting.

Therefore, it is not possible to extract the requested information (acceptance criteria, study details, etc.) from the provided text. This document is a regulatory approval notice, not a study report.

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