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FDA 510(k)

AMCATH DISPOSABLE CYTOLOGY BRUSH

K-Number: K923200 · 1992-12-07

ApplicantIntl. Medical, Inc.
Decision Date1992-12-07
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMCATH DISPOSABLE CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical, Inc.. It received FDA 510(k) clearance on 1992-12-07 under 510(k) number K923200. 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 AMCATH DISPOSABLE CYTOLOGY BRUSH?

AMCATH DISPOSABLE CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1992-12-07. The listed applicant is Intl. Medical, Inc.. The 510(k) number is K923200.

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

AMCATH DISPOSABLE CYTOLOGY BRUSH received FDA 510(k) clearance on 1992-12-07, under 510(k) number K923200.

Who is the listed applicant for AMCATH DISPOSABLE CYTOLOGY BRUSH?

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

What is the FDA product code for AMCATH DISPOSABLE CYTOLOGY BRUSH?

The FDA product code for AMCATH DISPOSABLE CYTOLOGY BRUSH is FDX.

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Other records listing Intl. Medical, Inc. as applicant

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K970507PEAK FLOW METERK943078HOT BIOPSY FORCEPSK940370AMERICAN CATHETER E.R.C.P. CANNULAK940335AMERICAN CATHETER POLY-SNAREK942068AMERICAN CATHETER SPHINCTEROTOMEK930406DURHAM; MIN BORE LUER LOCK EXTENSION SET

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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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