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FDA 510(k)

SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS

K-Number: K052695 · 2006-05-10

ApplicantSuretek Medical
Decision Date2006-05-10
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS is the device name listed in this FDA 510(k) record. The listed applicant is Suretek Medical. It received FDA 510(k) clearance on 2006-05-10 under 510(k) number K052695. 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 SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS?

SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Suretek Medical. The 510(k) number is K052695.

When did SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS receive FDA 510(k) clearance?

SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS received FDA 510(k) clearance on 2006-05-10, under 510(k) number K052695.

Who is the listed applicant for SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS?

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

What is the FDA product code for SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS?

The FDA product code for SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS is NUJ.

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Other records listing Suretek Medical 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.

K052691SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVESK052690SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTSK052692SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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