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FDA 510(k)

ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH

K-Number: K853530 · 1985-10-04

ApplicantE-Z-Em, Inc.
Decision Date1985-10-04
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853530. 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 ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH?

ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K853530.

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

ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853530.

Who is the listed applicant for ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH?

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

What is the FDA product code for ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH?

The FDA product code for ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH is FDX.

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Other records listing E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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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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