ReNovo, Inc.
FDA Regulatory Profile
ReNovo, Inc. appears in FDA public data with 1 recall, 6 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1159-2021, Class II) was initiated on January 19, 2021. Its most recent 510(k) clearance was granted on March 19, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1159-2021 | Class II | Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERIL | January 19, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173740 | Reprocessed DePuy Mitek Ablation Wand | March 19, 2018 |
| K173741 | Reprocessed ArthoCare Ablation Wand | March 5, 2018 |
| K172647 | Reprocessed ArthroCare ENT Coblator | February 21, 2018 |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | October 6, 2017 |
| K172093 | Reprocessed Covidien Trocar | October 5, 2017 |
| K172092 | Reprocessed Shavers/Burs | October 4, 2017 |