FDA 510(k)

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

Numéro K : K182588 · 2018-10-31

DemandeurSurgical Instrument Service and Savings Inc.(Dba Medline Ren

Date de décision2018-10-31

Code produitNUJ

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Medline ReNewal Reprocessed LigaSure Maryland Jaw 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 2018-10-31 under 510(k) number K182588. 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 Maryland Jaw Sealer/Divider?

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K182588.

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

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182588.

Who is the listed applicant for Medline ReNewal Reprocessed LigaSure Maryland Jaw 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 Maryland Jaw Sealer/Divider?

The FDA product code for Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is NUJ.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

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 Shears K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider K151617Livewire Electrophysiology Catheter

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 K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerStryker Sustainability Solutions

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.