Data / Medical devices / United States / Renovo, Inc.
Renovo, Inc.: FDA-registered device maker in Bend, OR, United States, 6 510(k) clearances
Renovo, Inc. is registered with the FDA (registration 3014023545) in Bend, OR, United States. It lists 27 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 19, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014023545
- Address
- 340 SW Columbia ST, Bend, OR, United States, 97702
- Owner or operator
- ReNovo, Inc (10054580)
- Roles
- Reprocessor
- First device listed
- October 9, 2017
- Registered through
- 2026
- Brand names listed
- ENT Shaver/Abrader, ReNovo Inc., ReNovo, Inc., ReNovo,Inc., Renovo, Inc.
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2018 | K173740 | Reprocessed DePuy Mitek Ablation Wand | NUJ | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| March 5, 2018 | K173741 | Reprocessed ArthoCare Ablation Wand | NUJ | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| February 21, 2018 | K172647 | Reprocessed ArthroCare ENT Coblator | NUJ | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| October 6, 2017 | K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | NLM | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| October 5, 2017 | K172093 | Reprocessed Covidien Trocar | NLM | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| October 4, 2017 | K172092 | Reprocessed Shavers/Burs | HRX | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 19, 2021 | 87258 | Class II | Ongoing | Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew | Non-sterile product was shipped to customers labelled as sterile. | accessdata.fda.gov |
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Updated March 19, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.