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FDA 510(k)

BERGER PROSTATE CULTURE CYTOLOGY BRUSH

K-Number: K880095 · 1988-03-02

ApplicantVan-Tec, Inc.
Decision Date1988-03-02
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BERGER PROSTATE CULTURE CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Van-Tec, Inc.. It received FDA 510(k) clearance on 1988-03-02 under 510(k) number K880095. 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 BERGER PROSTATE CULTURE CYTOLOGY BRUSH?

BERGER PROSTATE CULTURE CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1988-03-02. The listed applicant is Van-Tec, Inc.. The 510(k) number is K880095.

When did BERGER PROSTATE CULTURE CYTOLOGY BRUSH receive FDA 510(k) clearance?

BERGER PROSTATE CULTURE CYTOLOGY BRUSH received FDA 510(k) clearance on 1988-03-02, under 510(k) number K880095.

Who is the listed applicant for BERGER PROSTATE CULTURE CYTOLOGY BRUSH?

The FDA 510(k) record lists Van-Tec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BERGER PROSTATE CULTURE CYTOLOGY BRUSH?

The FDA product code for BERGER PROSTATE CULTURE CYTOLOGY BRUSH is FDX.

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Other records listing Van-Tec, 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.

K880096VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUPK880099VAN-TEC BLADDER EVACUATORK880098VAN-TEC AUTO BIOPSY NEEDLEK880094VAN-TEC ENDOPYELOTOMY KNIFEK874112VAN-TEC DOUBLE OCCLUSION BALLOON CATHETERK871777VAN-TEC REUSABLE HELICAL STONE BASKET

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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.K191485Deflectable Brush Biopsy SetCook IncorporatedK182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook IncorporatedK181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, 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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