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FDA 510(k)

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

K-Number: K153745 · 2016-05-02

ApplicantSurgical Instrument Service and Savings Inc.(Dba Medline Ren
Decision Date2016-05-02
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider is a medical device manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2016-05-02 under approval number K153745. 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 Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider?

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider is a medical device that received FDA 510(k) clearance on 2016-05-02. It is manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K153745.

When was Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider approved by the FDA?

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider received FDA 510(k) clearance on 2016-05-02, under approval number K153745.

What company makes Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider?

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider is manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren.

What is the FDA product code for Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider?

The FDA product code for Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider is NUJ.

Other Devices by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K151617Livewire Electrophysiology Catheter K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider K193563Medline ReNewal Reprocessed Harmonic ACE+7 Shears K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

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. 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. K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsSurgical 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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