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FDA 510(k)

WILTEK CYTOLOGY BRUSH

K-Number: K894863 · 1989-12-21

ApplicantWiltek Medical, Inc.
Decision Date1989-12-21
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Wiltek Medical, Inc.. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K894863. 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 WILTEK CYTOLOGY BRUSH?

WILTEK CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K894863.

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

WILTEK CYTOLOGY BRUSH received FDA 510(k) clearance on 1989-12-21, under 510(k) number K894863.

Who is the listed applicant for WILTEK CYTOLOGY BRUSH?

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

What is the FDA product code for WILTEK CYTOLOGY BRUSH?

The FDA product code for WILTEK CYTOLOGY BRUSH is FDX.

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Other records listing Wiltek Medical, 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.

K990231WILTEK HOT BIOPSY FORCEPSK922989WILTEK IRRIGAITON/ASPIRATION TUBE SETK930419WILTEK BIOPSY FORCEPSK914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERK914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERK914131WILTEK ELECTROCAUTERY ADAPTOR

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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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