FDA.reportPublic FDA data

510(k) K930348

Device
Combo Cath Wire-guided Cytology System
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K930348
Product code
FDX
Decision
Substantially Equivalent (SESE)
Decision date
1993-09-03
Date received
1993-01-25
Regulation
876.1500
Classification name
Endoscopic Cytology Brush
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WANDA CAPRINELLA
Address
2710 Orchard Pkwy. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FDX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation2025-12-18
K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.2022-07-28
K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.2019-11-14
K191485Deflectable Brush Biopsy SetCook Incorporated2019-06-26
K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated2019-05-01
K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.2019-02-08
K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd.2018-03-05
K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.2017-12-29
K171607Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy2017-07-31
K151889Infinity ERCP Sampling DeviceUnited States Endoscopy Group, Inc.2015-07-30
K103437US ENDOSCOPY CYTOLOGY BRUSHUnited States Endoscopy Group, Inc.2010-12-23
K052279COOK IRELAND ECHOBRUSHCook Ireland, Ltd.2005-10-11
K040324WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSHWilson-Cook Medical, Inc.2004-05-20
K021998HORIZONS CYTOLOGY BRUSHHorizons Intl. Corp.2002-07-12
K965037CELL RECOVERY SYSTEMMedical Device Technologies, Inc.1997-01-08