OCX — Endoscopic Irrigation/Suction System Class II
Classification Details
- Product Code
- OCX
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251986 | olympus medical systems corporation | AUXILIARY WATER TUBE MAJ-855 | September 26, 2025 |
| K251997 | olympus medical systems corporation | Single-Use Biopsy Valve (MAJ-1555) | September 25, 2025 |
| K242586 | ovesco endoscopy | ArgoCap (200.52) | May 22, 2025 |
| K241704 | hangzhou ags medtech co | Endoscopic Water Pump | March 20, 2025 |
| K242357 | olympus medical systems corporation | Water Container (MAJ-901); Water Container (MAJ-902) | October 7, 2024 |
| K241874 | hobbs medical | Aspiration Catheter (2189) | September 24, 2024 |
| K242134 | finemedix co | ClearCap Distal Attachment | August 20, 2024 |
| K233442 | biotex | troCarWash System | May 21, 2024 |
| K230773 | zhejiang chuangxiang medical technology co | Endoscopy Irrigation Tubing | November 21, 2023 |
| K231471 | zhejiang chuangxiang medical technology co | Air/Water Bottle Tubing, CO2 Source Tubing | September 8, 2023 |
| K231418 | medivators | ENDOGATOR Hybrid Irrigation Tubing | August 14, 2023 |
| K231602 | ga health company limited | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tub | August 1, 2023 |
| K230932 | ga health company limited | ANDORATE® Valve Kit | July 7, 2023 |
| K222173 | saneso | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | February 27, 2023 |
| K222695 | biotex | troCarWash System | February 17, 2023 |
| K223171 | ga health company limited | AquaPulse® Irrigation Tubing | November 10, 2022 |
| K222734 | diversatek healthcare | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | November 8, 2022 |
| K221310 | changzhou endoclean medical device co | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | October 7, 2022 |
| K220785 | yangzhou fartley medical instrument technology co | Clean Connecting Tube | September 27, 2022 |
| K221824 | cipher surgical limited | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpCl | August 19, 2022 |