OCX
- Product code
- OCX
- Device name
- Endoscopic Irrigation/Suction System
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 93 (all years; only the last 3 years are listed here)
FDA classification definition
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251986 | 2025-09-26 | Olympus Medical Systems Corporation | AUXILIARY WATER TUBE MAJ-855 | |
| K251997 | 2025-09-25 | Olympus Medical Systems Corporation | Single-Use Biopsy Valve (MAJ-1555) | |
| K242586 | 2025-05-22 | Ovesco Endoscopy AG | ArgoCap (200.52) | — |
| K241704 | 2025-03-20 | Hangzhou AGS MedTech Co., Ltd. | Endoscopic Water Pump | |
| K242357 | 2024-10-07 | Olympus Medical Systems Corporation | Water Container (MAJ-901); Water Container (MAJ-902) | |
| K241874 | 2024-09-24 | Hobbs Medical, Inc. | Aspiration Catheter (2189) | |
| K242134 | 2024-08-20 | Finemedix Co., Ltd. | ClearCap Distal Attachment | |
| K233442 | 2024-05-21 | Biotex, Inc. | troCarWash System | FDA |
| K230773 | 2023-11-21 | Zhejiang Chuangxiang Medical Technolog… | Endoscopy Irrigation Tubing |
Official FDA classification page: OCX
Classification and pathway per current FDA publications. Data from openFDA (CC0).