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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 the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2016-05-02 under 510(k) 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. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K153745.

When did Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider?

The FDA 510(k) record lists Surgical Instrument Service and Savings Inc.(Dba Medline Ren as the applicant. This does not by itself establish the device manufacturer.

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 records listing Surgical Instrument Service and Savings Inc.(Dba Medline Ren as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsK182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerK170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorK151617Livewire Electrophysiology Catheter

Related Devices (Code: NUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLCK191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLCK182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren

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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