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FDA 510(k)

Green OR Reprocessed Aquamantys Bipolar Sealer

K-Number: K211203 · 2022-04-07

ApplicantGreen Or, LLC
Decision Date2022-04-07
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Green OR Reprocessed Aquamantys Bipolar Sealer is a medical device manufactured by Green Or, LLC. It received FDA 510(k) clearance on 2022-04-07 under approval number K211203. 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 Green OR Reprocessed Aquamantys Bipolar Sealer?

Green OR Reprocessed Aquamantys Bipolar Sealer is a medical device that received FDA 510(k) clearance on 2022-04-07. It is manufactured by Green Or, LLC. The 510(k) number is K211203.

When was Green OR Reprocessed Aquamantys Bipolar Sealer approved by the FDA?

Green OR Reprocessed Aquamantys Bipolar Sealer received FDA 510(k) clearance on 2022-04-07, under approval number K211203.

What company makes Green OR Reprocessed Aquamantys Bipolar Sealer?

Green OR Reprocessed Aquamantys Bipolar Sealer is manufactured by Green Or, LLC.

What is the FDA product code for Green OR Reprocessed Aquamantys Bipolar Sealer?

The FDA product code for Green OR Reprocessed Aquamantys Bipolar Sealer is NUJ.

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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