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FDA 510(k)

GASTROINTESTINAL CYTOLOGY BRUSH

K-Number: K901435 · 1990-07-16

ApplicantTelemed Systems, Inc.
Decision Date1990-07-16
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 Telemed Systems, Inc.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K901435. 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 1990-07-16. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K901435.

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

GASTROINTESTINAL CYTOLOGY BRUSH received FDA 510(k) clearance on 1990-07-16, under 510(k) number K901435.

Who is the listed applicant for GASTROINTESTINAL CYTOLOGY BRUSH?

The FDA 510(k) record lists Telemed Systems, Inc. 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 Telemed Systems, 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.

K020379PPD BALLOON DILATATION CATHETERK013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONK010412FLEXIBLE ENDOSCOPIC SCISSORSK9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCHK992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATDK974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR

View all 22 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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