ReNovo, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1159-2021Class IIVarious reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILJanuary 19, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K173740Reprocessed DePuy Mitek Ablation WandMarch 19, 2018
K173741Reprocessed ArthoCare Ablation WandMarch 5, 2018
K172647Reprocessed ArthroCare ENT CoblatorFebruary 21, 2018
K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesOctober 6, 2017
K172093Reprocessed Covidien TrocarOctober 5, 2017
K172092Reprocessed Shavers/BursOctober 4, 2017