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FDA 510(k)

SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH

K-Number: K130357 · 2013-11-06

ApplicantCovidien, LLC
Decision Date2013-11-06
Product CodeBTG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2013-11-06 under 510(k) number K130357. The device is classified under product code BTG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH?

SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 2013-11-06. The listed applicant is Covidien, LLC. The 510(k) number is K130357.

When did SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH receive FDA 510(k) clearance?

SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH received FDA 510(k) clearance on 2013-11-06, under 510(k) number K130357.

Who is the listed applicant for SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH?

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

What is the FDA product code for SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH?

The FDA product code for SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH is BTG.

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Related Devices (Code: BTG)

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K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems CorporationK182927Pulmonary Cytology BrushHobbs Medical, Inc.K190293Single Use Cytology Brush BC-205DOlympus Medical Systems Corp.K820771MICROBIOLOGY SPECIMEN BRUSHMill-Rose LaboratoryK780872CYTOLOGY BRUSHCooperVision, 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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