Renovo, Inc.
United StatesFDA applicant, unverified FDA FEI 3014023545
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Renovo, Inc. makes
Renovo, Inc. reprocesses single-use medical devices, including shavers/burs, Ethicon bladeless trocars and universal trocar sleeves, Covidien trocars, DePuy Mitek ablation wands, ArthroCare ENT Coblators, and ArthroCare ablation wands.
These reprocessed devices are classified as Class II and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Reprocessed Shavers/Burs Ref K172092
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Reprocessed Covidien Trocar Ref K172093
Regimes: 510(k) Registry: 510(k)Reprocessed DePuy Mitek Ablation Wand Ref K173740
Regimes: 510(k) Registry: 510(k)Reprocessed ArthroCare ENT Coblator Ref K172647
Regimes: 510(k) Registry: 510(k)Reprocessed ArthoCare Ablation Wand Ref K173741
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3014023545
- Address
- 340 SW COLUMBIA ST, Bend, OR, 97702
FDA recalls
FDA recall records list 1 recall initiated by Renovo, Inc., initiated on 2021-01-19. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 19 Jan 2021 Z-1159-2021 Class II Ongoing Non-sterile product was shipped to customers labelled as sterile.
Frequently asked questions
How many devices does Renovo, Inc. have in the registry?
The registry currently lists 6 devices for Renovo, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Renovo, Inc.'s devices?
Among its 6 most recently registered devices, Renovo, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Renovo, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Renovo, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Renovo, Inc.?
FDA recall records list 1 recall initiated by Renovo, Inc., the most recent initiated on 19 Jan 2021. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Renovo, Inc. in the registry?
The most recently registered devices listed for Renovo, Inc. include Reprocessed Shavers/Burs, Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves, Reprocessed Covidien Trocar and Reprocessed DePuy Mitek Ablation Wand.