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FDA 510(k)

Reprocessed ArthroCare ENT Coblator

K-Number: K172647 · 2018-02-21

ApplicantRenovo, Inc.
Decision Date2018-02-21
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reprocessed ArthroCare ENT Coblator is a medical device manufactured by Renovo, Inc.. It received FDA 510(k) clearance on 2018-02-21 under approval number K172647. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed ArthroCare ENT Coblator?

Reprocessed ArthroCare ENT Coblator is a medical device that received FDA 510(k) clearance on 2018-02-21. It is manufactured by Renovo, Inc.. The 510(k) number is K172647.

When was Reprocessed ArthroCare ENT Coblator approved by the FDA?

Reprocessed ArthroCare ENT Coblator received FDA 510(k) clearance on 2018-02-21, under approval number K172647.

What company makes Reprocessed ArthroCare ENT Coblator?

Reprocessed ArthroCare ENT Coblator is manufactured by Renovo, Inc..

What is the FDA product code for Reprocessed ArthroCare ENT Coblator?

The FDA product code for Reprocessed ArthroCare ENT Coblator is NUJ.

Other Devices by Renovo, Inc.

K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves K172093Reprocessed Covidien Trocar K172092Reprocessed Shavers/Burs K173740Reprocessed DePuy Mitek Ablation Wand K173741Reprocessed ArthoCare Ablation Wand

Related Devices (Code: NUJ)

K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)Sterilmed, Inc. K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc. K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren K152134Reprocessed Vessel SealerSterilmed, Inc. K152313Medline ReNewal Reprocessed Endopath Endoscopic InstrumentsSurgical Instrument Services and Savings, Inc. K172608Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesSurgical Instrument Service and Savings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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