FDA 510(k)

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

Numéro K : K153745 · 2016-05-02

DemandeurSurgical Instrument Service and Savings Inc.(Dba Medline Ren

Date de décision2016-05-02

Code produitNUJ

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Surgical Instrument Service and Savings Inc.(Dba Medline Ren en tant que demandeur

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Dispositifs connexes (Code : NUJ)

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 Solutions K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC K191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren

Source officielle

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