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FDA 510(k)

Deflectable Brush Biopsy Set

K-Number: K191485 · 2019-06-26

ApplicantCook Incorporated
Decision Date2019-06-26
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Deflectable Brush Biopsy Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-06-26 under 510(k) number K191485. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deflectable Brush Biopsy Set?

Deflectable Brush Biopsy Set is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Cook Incorporated. The 510(k) number is K191485.

When did Deflectable Brush Biopsy Set receive FDA 510(k) clearance?

Deflectable Brush Biopsy Set received FDA 510(k) clearance on 2019-06-26, under 510(k) number K191485.

Who is the listed applicant for Deflectable Brush Biopsy Set?

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

What is the FDA product code for Deflectable Brush Biopsy Set?

The FDA product code for Deflectable Brush Biopsy Set is FDX.

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Related Devices (Code: FDX)

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.

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems CorporationK220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook IncorporatedK181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd.

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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