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FDA 510(k)

Reprocessed Vessel Sealer

K-Number: K152134 · 2016-01-15

ApplicantSterilmed, Inc.
Decision Date2016-01-15
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reprocessed Vessel Sealer is a medical device manufactured by Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-01-15 under approval number K152134. 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 Reprocessed Vessel Sealer?

Reprocessed Vessel Sealer is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Sterilmed, Inc.. The 510(k) number is K152134.

When was Reprocessed Vessel Sealer approved by the FDA?

Reprocessed Vessel Sealer received FDA 510(k) clearance on 2016-01-15, under approval number K152134.

What company makes Reprocessed Vessel Sealer?

Reprocessed Vessel Sealer is manufactured by Sterilmed, Inc..

What is the FDA product code for Reprocessed Vessel Sealer?

The FDA product code for Reprocessed Vessel Sealer is NUJ.

Other Devices by Sterilmed, Inc.

K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter K152090Reprocessed Steerable Introducer K190478Reprocessed ViewFlex™ Xtra ICE Catheter K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

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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 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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