510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ReNovo, Inc.

Bend, OR, US

RENOVO, INC. appears in FDA device records in Bend, OR. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for ReNovo, Inc. between 2017 and 2018. The busiest year on record is 2017, with 3. The most recent is 2018, with 3.

Clearances by year, as a table
510(k) clearance decisions for ReNovo, Inc., by decision year
YearClearances
20173
20183
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173740Reprocessed DePuy Mitek Ablation WandNUJSubstantially Equivalent
K173741Reprocessed ArthoCare Ablation WandNUJSubstantially Equivalent
K172647Reprocessed ArthroCare ENT CoblatorNUJSubstantially Equivalent
K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesNLMSubstantially Equivalent
K172093Reprocessed Covidien TrocarNLMSubstantially Equivalent
K172092Reprocessed Shavers/BursHRXSubstantially Equivalent

Registered establishments

FDA registered establishments for ReNovo, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30140235453014023545RENOVO, INC.340 SW COLUMBIA ST, Bend, OR 97702 US2026and 17 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1159-2021Various 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 Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.Non-sterile product was shipped to customers labelled as sterile.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain