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FDA 510(k)

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

K-Number: K171324 · 2017-06-23

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2017-06-23
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K171324. 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 ArthroCare ArthroWands and Smith & Nephew Dyonics?

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K171324.

When did Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics receive FDA 510(k) clearance?

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics received FDA 510(k) clearance on 2017-06-23, under 510(k) number K171324.

Who is the listed applicant for Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics?

The FDA product code for Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics is NUJ.

Other records listing Surgical Instrument Service and Savings, 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.

K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerK252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterK250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterK250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

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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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