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FDA 510(k)

UROLOGICAL BIOPSY BRUSH SET

K-Number: K770913 · 1977-06-01

ApplicantCook, Inc.
Decision Date1977-06-01
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLOGICAL BIOPSY BRUSH SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1977-06-01 under 510(k) number K770913. 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 UROLOGICAL BIOPSY BRUSH SET?

UROLOGICAL BIOPSY BRUSH SET is a medical device that received FDA 510(k) clearance on 1977-06-01. The listed applicant is Cook, Inc.. The 510(k) number is K770913.

When did UROLOGICAL BIOPSY BRUSH SET receive FDA 510(k) clearance?

UROLOGICAL BIOPSY BRUSH SET received FDA 510(k) clearance on 1977-06-01, under 510(k) number K770913.

Who is the listed applicant for UROLOGICAL BIOPSY BRUSH SET?

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

What is the FDA product code for UROLOGICAL BIOPSY BRUSH SET?

The FDA product code for UROLOGICAL BIOPSY BRUSH SET is FDX.

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Other records listing Cook, 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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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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