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FDA 510(k)

ENDOSCOPIC CYTOLOGY BRUSHES

K-Number: K791668 · 1979-10-01

ApplicantMill-Rose Laboratory
Decision Date1979-10-01
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC CYTOLOGY BRUSHES is the device name listed in this FDA 510(k) record. The listed applicant is Mill-Rose Laboratory. It received FDA 510(k) clearance on 1979-10-01 under 510(k) number K791668. 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 ENDOSCOPIC CYTOLOGY BRUSHES?

ENDOSCOPIC CYTOLOGY BRUSHES is a medical device that received FDA 510(k) clearance on 1979-10-01. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K791668.

When did ENDOSCOPIC CYTOLOGY BRUSHES receive FDA 510(k) clearance?

ENDOSCOPIC CYTOLOGY BRUSHES received FDA 510(k) clearance on 1979-10-01, under 510(k) number K791668.

Who is the listed applicant for ENDOSCOPIC CYTOLOGY BRUSHES?

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

What is the FDA product code for ENDOSCOPIC CYTOLOGY BRUSHES?

The FDA product code for ENDOSCOPIC CYTOLOGY BRUSHES is FDX.

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Other records listing Mill-Rose Laboratory 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.

K983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KITK983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KITK971275MILL-ROSE DISPOSABLE POLYPECTOMY SNAREK962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLEK960880MILL-ROSE BLIND MICROBIOLOGY BRUSHK954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

View all 46 devices →

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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