OCX — Endoscopic Irrigation/Suction System Class II
FDA product code OCX covers "Endoscopic Irrigation/Suction System", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |