FDA WARNING_LETTER - ReNovo, Inc. - May 18, 2023

On October 13, 2023, the FDA issued a Warning Letter to Mr. Mansberger, following an inspection of his firm in Bend, OR, from May 15-18, 2023. The firm reprocesses and distributes single-use devices, including Electrosurgical Ablation Wands, ENT Coblators, Trocars, ENT Burs, Drill Bits, and Surgical Saw Blades.

The inspection revealed that several devices are adulterated because the firm lacks approved Premarket Approval (PMA) applications or Investigational Device Exemptions. Additionally, the devices are misbranded as the firm failed to notify the FDA of its intent to introduce them into commercial distribution, as required by section 510(k) of the Act.

Specifically, the firm added new models of devices (e.g., Electrosurgical Ablation Wands, ENT Coblators, Trocars, ENT Burs, Drill Bits, and Surgical Saw Blades) via "Letter to File" that were not cleared under existing 510(k)s (K173741, K173740, K172647, K172097, K172093). These new models, often with smaller diameters, lumens, or different design features, present more challenging cleaning and re-sterilization scenarios. The firm did not evaluate how these design changes