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FDA 510(k)

GASTROINTESTINAL CYTOLOGY BRUSH

K-Number: K860997 · 1986-05-02

ApplicantEndovations
Decision Date1986-05-02
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTROINTESTINAL CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K860997. 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 GASTROINTESTINAL CYTOLOGY BRUSH?

GASTROINTESTINAL CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Endovations. The 510(k) number is K860997.

When did GASTROINTESTINAL CYTOLOGY BRUSH receive FDA 510(k) clearance?

GASTROINTESTINAL CYTOLOGY BRUSH received FDA 510(k) clearance on 1986-05-02, under 510(k) number K860997.

Who is the listed applicant for GASTROINTESTINAL CYTOLOGY BRUSH?

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

What is the FDA product code for GASTROINTESTINAL CYTOLOGY BRUSH?

The FDA product code for GASTROINTESTINAL CYTOLOGY BRUSH is FDX.

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Other records listing Endovations 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.

K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERK942110INJECT-SNAREK934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOMEK9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHK9138705MM MICROSCISSORSK911155OVAL CUP BIOPSY FORCEP

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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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