ReNovo, Inc. DBA Provision Device Reprocessing Solutions

Warning LetterOpen

Kirk M. Mansberger President ReNovo, Inc. DBA Provision Device Reprocessing Solutions 340 SW Columbia St. Bend , OR 97702-1035 United StatesIssued Oct 13, 2023Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations4

Issue DateOct 13, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: ReNovo, Inc. DBA Provision Device Reprocessing Solutions
Location: Kirk M. Mansberger President ReNovo, Inc. DBA Provision Device Reprocessing Solutions 340 SW Columbia St. Bend , OR 97702-1035 United States
FEI Number: N/A
Country: United States
Issue Date: October 13, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

ReNovo, Inc., a device reprocessor and distributor of reprocessed single-use medical devices including electrosurgical ablation wands, coblators, trocars, and surgical instruments, was cited for distributing adulterated devices without approved premarket approval (PMA) applications or investigational device exemptions as required under the Federal Food, Drug, and Cosmetic Act. The FDA inspection conducted May 15-18, 2023 at the company's Bend, Oregon facility identified multiple reprocessed device models that lacked the required regulatory authorizations for commercial distribution. The company's response to the FDA's initial inspection observations did not adequately address the agency's compliance concerns regarding the unauthorized distribution of these Class II and higher-risk medical devices.

ReNovo, Inc. DBA Provision Device Reprocessing Solutions FDA Warning Letter, October 13, 2023