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FDA 510(k)

Reprocessed DePuy Mitek Ablation Wand

K-Number: K173740 · 2018-03-19

ApplicantRenovo, Inc.
Decision Date2018-03-19
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reprocessed DePuy Mitek Ablation Wand is a medical device manufactured by Renovo, Inc.. It received FDA 510(k) clearance on 2018-03-19 under approval number K173740. 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 DePuy Mitek Ablation Wand?

Reprocessed DePuy Mitek Ablation Wand is a medical device that received FDA 510(k) clearance on 2018-03-19. It is manufactured by Renovo, Inc.. The 510(k) number is K173740.

When was Reprocessed DePuy Mitek Ablation Wand approved by the FDA?

Reprocessed DePuy Mitek Ablation Wand received FDA 510(k) clearance on 2018-03-19, under approval number K173740.

What company makes Reprocessed DePuy Mitek Ablation Wand?

Reprocessed DePuy Mitek Ablation Wand is manufactured by Renovo, Inc..

What is the FDA product code for Reprocessed DePuy Mitek Ablation Wand?

The FDA product code for Reprocessed DePuy Mitek Ablation Wand is NUJ.

Other Devices by Renovo, Inc.

K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves K172093Reprocessed Covidien Trocar K172092Reprocessed Shavers/Burs K173741Reprocessed ArthoCare Ablation Wand K172647Reprocessed ArthroCare ENT Coblator

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

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

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