FDA.reportPublic FDA data

Endoscope working-channel valve, single-use

Definition
A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.
GUDID devices
105
Last updated
2026-08-28 10:21:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
14953170152433SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.MAJ-2102016-09-21
14953170154291SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.MAJ-12182016-09-21
14953170247573SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.MAJ-15552016-09-21
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.MAJ-15552025-09-30
00724995183486BioShieldUS Endoscopy007111242020-03-19
00724995183509BioShieldUS Endoscopy007111262020-03-19
00724995183516BioShieldUS Endoscopy007111272020-03-19
00724995183523BioShieldUS Endoscopy007111282020-03-19
00724995183554BioShieldUS Endoscopy007111332020-03-19
00724995183561BioShieldUS Endoscopy007111342020-03-19
00724995183578BioShieldUS Endoscopy007111352020-03-19
00724995183585BioShieldUS Endoscopy007111362020-03-19
00724995183592BioShieldUS Endoscopy007111372020-03-19
00724995190767UroSealUS Endoscopy009134102020-04-02
00724995199241BioShieldUS Endoscopy007119022021-09-15
00724995199258BioShieldUS Endoscopy007119032021-09-15
00724995211530UroSealUS Endoscopy009134102022-11-28
00816765011034BioShieldUS Endoscopy007111242016-09-17
00816765011058BioShieldUS Endoscopy007111262016-09-17
00816765011065BioShieldUS Endoscopy007111272016-09-17
00816765011072BioShieldUS Endoscopy007111282016-09-17
00816765011102BioShieldUS Endoscopy007111332016-09-17
00816765011119BioShieldUS Endoscopy007111342016-09-17
00816765011126BioShieldUS Endoscopy007111352016-09-17
00816765011133BioShieldUS Endoscopy007111362016-09-17
00816765011140BioShieldUS Endoscopy007111372016-09-17
00816765012482UroSealUS Endoscopy009134102016-09-17
00816765012994BioGuardUS Endoscopy007117832017-02-22
00816765013007BioGuardUS Endoscopy007117842017-02-22
00850025860741Disposable Biopsy ValveMicro-tech UsaBW01-OLYB2025-03-04
00850025860765Disposable Biopsy ValveMicro-tech UsaBW01-PENB2025-03-04
00858276007243Jacket Biopsy ValveMicro-tech UsaMD-A-BV022025-03-03
00858276007335Jacket Biopsy ValveMicro-tech UsaMD-B-BV022025-03-03
04044503002341FUJIFILM medworkFUJIFILM medwork GmbHVAL1-G7-4-50-12024-07-31
04547410079326FUJIFILMFUJIFILM CORPORATIONFOV-DV72022-10-07
04547410079357FUJIFILMFUJIFILM CORPORATIONFOV-LL22022-10-07
04547410391220FUJIFILMFUJIFILM CORPORATIONFV-0012022-10-07
04547410426380FUJIFILMFUJIFILM CORPORATIONFV-0022022-10-07
04547410480993FUJIFILMFUJIFILM CORPORATIONFV-0032022-12-02
04897106950270andorate® Disposable Biopsy ValveGA Health Company LimitedGAR028-S2020-05-28
04897106950287andorate® Disposable Biopsy ValveGA Health Company LimitedGAR0282020-08-05
04897106950379andorate® Disposable Biopsy ValveGA Health Company LimitedGAR018-S2020-08-07
04897106950386andorate® Disposable Biopsy ValveGA Health Company LimitedGAR018P-S2020-05-28
04897106953479andorate® Biopsy ValveGA Health Company LimitedGABV-012021-03-12
04897106953684andorate® Biopsy ValveGA Health Company LimitedGAR0182021-03-12
04897106953691andorate® Biopsy ValveGA Health Company LimitedGAR018P2020-12-11
04897106953707andorate® Biopsy ValveGA Health Company LimitedGAR0282021-03-12
04897106953714andorate® Biopsy ValveGA Health Company LimitedGABV-022021-03-12
04897106953752andorate® Biopsy ValveGA Health Company LimitedGAR028-S2022-01-11
04897106953899andorate® Biopsy IrrigatorGA Health Company LimitedGAR0152022-01-28
04897106953905andorate® Biopsy ValveGA Health Company LimitedGAR018P-S2022-01-10
04897106954001andorate® Biopsy ValveGA Health Company LimitedGAR018-S2022-01-10
04897106954100STOPCON Biopsy Valve For Pentax® GI-EndoscopeGA Health Company LimitedEN10234B2022-01-31
04897106955077Biopsy ValveGA Health Company LimitedEN10233OL2022-03-25
04897106955169andorate® Biopsy ValveGA Health Company LimitedGAR0212024-10-04
06932503554510EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.NT-E-30/23-P2025-04-24
06932503554527EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.NT-E-30/16-P2025-04-24
06944932785113WelleadWell Lead Medical Co.,LtdU04D0101102022-01-26
06944932785120WelleadWell Lead Medical Co.,LtdU04D0201102022-01-26
06970401814343Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., LTD.MD-A-BV012019-12-24
06970401817139Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., LTD.MD-A-BV022020-08-26
06970401817146Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., LTD.MD-B-BV022020-08-26
06970661241545Andorate®Smartdata Suzhou Co., Ltd.GAR028S2018-10-02
08714729746676RX Locking Device and Biopsy CapBOSTON SCIENTIFIC CORPORATIONM005452602016-09-24
08714729746683RX Locking Device and Biopsy CapBOSTON SCIENTIFIC CORPORATIONM005452702016-09-24
08714729746690RX Locking Device and Biopsy CapBOSTON SCIENTIFIC CORPORATIONM005452802016-09-24
08714729753032UroLok II AdaptorBOSTON SCIENTIFIC CORPORATIONM00673014002016-09-24
08714729858614Gateway AdvantageBOSTON SCIENTIFIC CORPORATIONM00673015002016-09-24
08714729981596Seal®BOSTON SCIENTIFIC CORPORATIONSBC-5012018-10-22
08714729994701AutoCap™ RXBOSTON SCIENTIFIC CORPORATIONM005451002021-06-24
10653405063230CONMED CLEARGUARDConmed Corporation0005222017-09-15
10653405063261CONMED CLEARGUARDConmed Corporation0005232017-09-15
10724995183490BioShieldUS Endoscopy007111252020-03-19
10724995183537BioShieldUS Endoscopy007111292020-03-19
10724995183544BioShieldUS Endoscopy007111312020-03-19
10816765013394BioShieldUS Endoscopy007111252016-09-17
10816765013400BioShieldUS Endoscopy007111292016-09-17
10884521539747EdgeCovidien LPSD300BAPK2016-09-24
10884521539754EdgeCovidien LPSD301BAPK2016-09-24
10884521539761EdgeCovidien LPSD302BAPK2016-09-24