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ODC · Endoscope Channel Accessory

Gastroenterology, Urology · 40 clearances · 23 unique sponsors

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Device class
Class II
Regulation 876.1500
Total clearances
40
2020-05-14 → 2026-06-12
Last 12 months
3
Unique sponsors
23
Definition

What is Endoscope Channel Accessory

To give the endoscope channel additional or improved functionality.
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.1500
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
STERIS Corporation 7 0 2024-11-08
Ga Health Company Limited 4 0 2023-10-16
Yangzhou Fartley Medical Instrument Technology Co., Ltd. 3 0 2025-06-20
Medivators (A Subsidiary of Steris Corporation) 3 0 2024-03-22
Olympus Medical Systems Corporation 2 0 2025-07-16
Boston Scientific Corporation 2 1 2025-10-09
Changzhou Endoclean Medical Device Co., Ltd. 2 0 2023-11-29
Fujifilm Medwork GmbH 2 0 2022-06-01
Pentax of America, Inc. 1 0 2023-12-01
Well Lead Medical Co., Ltd. 1 0 2022-01-14
Wilson Cook Medical 1 0 2022-04-26
Wilson Instruments (Sha) Co., Ltd. 1 0 2021-01-06
Endostart S.R.L. 1 0 2024-03-15
Sml Med-Tech Solutions Limited 1 0 2023-01-17
Endosound, Inc. 1 1 2025-10-17
Steris Corporations 1 0 2021-01-08
Dyne Medical Group, Inc. 1 1 2026-06-12
Shanghai SeeGen Photoelectric Technology Co., Ltd. 1 0 2023-11-22
Micro-Tech (Nanjing) Co., Ltd. 1 0 2022-03-29
Hangzhou AGS MedTech Co., Ltd. 1 0 2020-12-23
Steris Corparation 1 0 2025-02-20
Alton (Shanghai) Medical Instruments Co., Ltd. 1 0 2024-10-01
Anrei Medical (Hangzhou) Co., Ltd. 1 0 2020-05-14
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4649 HCPCS Surgical supply; miscellaneous ✓ CMS-verified description Medium Endoscope channel accessory supply code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-12 K252933 Dyne Medical Group, Inc. DYNE PORT
2025-10-17 K250145 Endosound, Inc. Biopsy Port Adapter
2025-10-09 K252910 Boston Scientific Orca Air/Water and Suction Valves
2025-07-16 K250949 Olympus Medical Systems Corporation Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
2025-06-20 K250732 Yangzhou Fartley Medical Instrument Technology Co., Ltd. Disposable Endoscopy Valve Set
2025-03-19 K241842 Olympus Medical Systems Corporation Luer-Split MAJ-2092
2025-02-20 K250140 Steris Corparation Defendo Fujifilm 700 Single Use Cleaning Adapter
2024-11-08 K243075 STERIS Corporation Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
2024-10-11 K242742 STERIS Corporation DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
2024-10-01 K241285 Alton (Shanghai) Medical Instruments Co., Ltd. Disposable Endoscope Valves Set (AF series)
2024-03-22 K232067 Medivators (A Subsidiary of Steris Corporation) Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
2024-03-15 K232327 Endostart S.R.L. Endorail
2024-03-06 K240352 STERIS Corporation Defendo Single Use Cleaning Adapter for Olympus Endoscopes
2024-03-06 K232004 Medivators (A Subsidiary of Steris Corporation) Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
2024-02-09 K240098 STERIS Corporation DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
2023-12-21 K232329 Medivators (A Subsidiary of Steris Corporation) Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
2023-12-01 K232249 Pentax of America, Inc. PENTAX Medical Gas/Water Feeding Valve OE-B14
2023-11-29 K232244 Changzhou Endoclean Medical Device Co., Ltd. Disposable Endoscope Valves System
2023-11-22 K222499 Shanghai SeeGen Photoelectric Technology Co., Ltd. Disposable Endoscope Valves Kit
2023-10-20 K232951 Steris BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
2023-10-16 K232118 Ga Health Company Limited ANDORATE® Valve Kit
2023-01-17 K220884 Sml Med-Tech Solutions Limited Disposable Endoscope Valve Sets
2022-11-21 K222980 Yangzhou Fartley Medical Instrument Technology Co., Ltd. Pentax Medical Valve Set
2022-09-08 K221331 Changzhou Endoclean Medical Device Co., Ltd. Disposable Endoscope Valves System
2022-06-17 K220210 Yangzhou Fartley Medical Instrument Technology Co., Ltd. Disposable Endoscopy Adapter Set
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence