Home › Device types › OCX
Endoscopic Irrigation/Suction System
FDA product code OCX · Class 2 · Gastroenterology, Urology
471
Registered devices
261
Adverse events
18
Recalls
93
510(k) clearances
Devices with this code
ELUXEO Tubing — NISSHA MEDICAL TECHNOLOGIES SASAir/Water Bottle CO2 Tubing — Micro-tech UsaCS-SZ10-30 OpClear Disposable — CIPHER SURGICAL LIMITEDClearCap Distal Attachment — FINEMEDIX CO.,LTD.andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit — GA Health Company Limitedandorate® Disposable Endoscope Valves Set — GA Health Company LimitedAndorate — Smartdata Suzhou Co., Ltd.andorate® Disposable Endoscope Valves Set — GA Health Company LimitedN/A — PENTAX OF AMERICA, INC.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.ENDOGATOR Kit — MEDIVATORS INC.andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit — GA Health Company LimitedEndogator Kit — MEDIVATORS INC.ENDOGATOR Kit — MEDIVATORS INC.ERBE — Erbe Elektromedizin GmbHENDOGATOR hybrid irrigation tubing — MEDIVATORS INC.ENDOGATOR Kit — MEDIVATORS INC.Clean Connecting Tube — Yangzhou Fartley Medical Instrument Technology Co., LtdENDOGATOR Kit — MEDIVATORS INC.Torrent — US Endoscopyandorate® Suction Valve — GA Health Company LimitedOlympus — KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDGlo-Tip — COOK INCORPORATEDBayou™ troCarWash System Disposable Kit — BIOTEX, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-31 | Erbe Medical, LLC | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to |
| 2026-03-31 | Erbe Medical, LLC | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9 |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9 |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
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