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FDA 510(k)

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

K-Number: K161086 · 2016-09-20

ApplicantSterilmed, Inc.
Decision Date2016-09-20
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-09-20 under 510(k) number K161086. 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 Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)?

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Sterilmed, Inc.. The 510(k) number is K161086.

When did Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) receive FDA 510(k) clearance?

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) received FDA 510(k) clearance on 2016-09-20, under 510(k) number K161086.

Who is the listed applicant for Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)?

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 Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)?

The FDA product code for Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) is NUJ.

Other records listing Sterilmed, Inc. as applicant

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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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