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FDA 510(k)

CYTOLOGY BRUSH

K-Number: K913248 · 1991-09-30

ApplicantAnnex Medical, Inc.
Decision Date1991-09-30
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Annex Medical, Inc.. It received FDA 510(k) clearance on 1991-09-30 under 510(k) number K913248. 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 CYTOLOGY BRUSH?

CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1991-09-30. The listed applicant is Annex Medical, Inc.. The 510(k) number is K913248.

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

CYTOLOGY BRUSH received FDA 510(k) clearance on 1991-09-30, under 510(k) number K913248.

Who is the listed applicant for CYTOLOGY BRUSH?

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

What is the FDA product code for CYTOLOGY BRUSH?

The FDA product code for CYTOLOGY BRUSH is FDX.

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Other records listing Annex 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.

K954377FORCEPS, GRASPING, FLEXIBLE ENDOSCOPICK952863FORCEPS, BIOPSY, NON-ELECTRICK951532METAL URETERAL BASKET STONE DISLODGERK951761METEL URETERAL BASKET STONE DISLODGERK934636ANNEX MEDICAL FLAT WIRE STONE EXTRACTORK934598GRASPING FORCEPS OR RETRIEVAL FORCEPS

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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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