Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

K-Number: K182588 · 2018-10-31

ApplicantSurgical Instrument Service and Savings Inc.(Dba Medline Ren
Decision Date2018-10-31
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

When was Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider approved by the FDA?

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

What company makes Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider?

Medline ReNewal Reprocessed LigaSure Maryland Jaw 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 Maryland Jaw Sealer/Divider?

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

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

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

↑