Endoscope Channel Accessory
Gastroenterology, Urology · 21 CFR 876.1500
To give the endoscope channel additional or improved functionality.
Recent MDR events
666 adverse event reports on file
- Orca?Jul 30, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03100
- OrcaPod?Jul 30, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03101
- Orca?Jul 30, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03102
- OrcaPod?Jul 29, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03082
- OrcaJul 29, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03081
- OrcaJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03067
- OrcaPod?Jul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03068
- DEFENDO Biopsy Valve IrrigatorJul 27, 2026InjuryMedivators Inc.1651395-2026-00013
- OrcaJul 27, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03046
- OrcaJul 27, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03047
Event type breakdown
Recalls
3 recall events for this product code
- Boston Scientific CorporationOpen, ClassifiedJun 11, 2026
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water functio
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Z-2413-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedMar 20, 2026
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Z-1610-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedMar 20, 2026
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Z-1611-2026 · View FDA record ↗
Registered firms
154 firms currently registered for this product code
Synergy Health Ast, Srl
Alajuela, CR
Bq Plus Medical Co.,ltd
SONGJIANG Shanghai, CN
Boston Scientific Limited
GALWAY, IE
Cook Medical Llc
Bloomington, IN, US
United States Endoscopy Group, Inc.
Mentor, OH, US
Alton Shanghai Medical Instruments Co Ltd
Shanghai, CN
Smartdata Suzhou Co., Ltd
Suzhou Jiangsu, CN
Isomedix Operations, Inc
ONTARIO, CA, US
Hoya Corporation Pentax Lifecare Division
KURIHARA-SHI Miyagi, JP
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou Zhejiang, CN
Shanghai Seegen Photoelectric Technology Co., Ltd
Shanghai, CN
Ga Health Vietnam Company Limited
Ho Chi Minh Tay Ninh, VN
The Ruhof Corporation
Mineola, NY, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Boston Scientific Limited
CORK Munster, IE
Shanghai Seegen Photoelectric Technology Co., Ltd
Shanghai, CN
Lynx Medical Pennsylvania
ERIE, PA, US
Ga Health Company Limited
Hong Kong, HK
Sml Med-tech Solutions Limited
Hong Kong, HK
510(k) clearances
72 clearances for this product code
- Dyne Medical Group, Inc.Jun 12, 2026
K252933 · DYNE PORT
- Endosound, Inc.Oct 17, 2025
K250145 · Biopsy Port Adapter
- Boston ScientificOct 9, 2025
K252910 · Orca Air/Water and Suction Valves
- Olympus Medical Systems CorporationJul 16, 2025
K250949 · Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.Jun 20, 2025
K250732 · Disposable Endoscopy Valve Set
- Olympus Medical Systems CorporationMar 19, 2025
K241842 · Luer-Split MAJ-2092
- Steris CorparationFeb 20, 2025
K250140 · Defendo Fujifilm 700 Single Use Cleaning Adapter
- STERIS CorporationNov 8, 2024
K243075 · Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)