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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 the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) 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. The listed applicant is Sterilmed, Inc.. The 510(k) number is K152134.

When did Reprocessed Vessel Sealer receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprocessed Vessel Sealer?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Vessel Sealer?

The FDA product code for Reprocessed Vessel Sealer is NUJ.

Other records listing Sterilmed, Inc. 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.

K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterK190478Reprocessed ViewFlex™ Xtra ICE CatheterK190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyK182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisK161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters

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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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