Home › Device types › OCX
Endoscopic Irrigation/Suction System
FDA product code OCX · Class 2 · Gastroenterology, Urology
474
Registered devices
277
Adverse events
18
Recalls
93
510(k) clearances
Devices with this code
Bayou™ troCarWash System Disposable Kit — BIOTEX, INC.OrcaPod™ — BOSTON SCIENTIFIC CORPORATIONBioShield — US EndoscopyAir/Water Bottle CO2 Tubing — Micro-tech Usaandorate® Disposable Endoscope Valves Set — GA Health Company LimitedENDO-GATOR — PENTAX OF AMERICA, INC.ERBE — Erbe Elektromedizin GmbHENDOGATOR — MEDIVATORS INC.ENDOGATOR — MEDIVATORS INC.andorate® 3-piece Valve Kit — GA Health Company LimitedCS-SZ10-00 OpClear Disposable — CIPHER SURGICAL LIMITEDProtego Air Water Bottle Tubing — GA Health Company Limited3-piece valve kit (Suction, Air/Water and Biopsy Valves) — GA Health Company Limitedandorate® Air/Water Bottle Tubing with Side Port — GA Health Company Limitedandorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit — GA Health Company LimitedClean Connecting Tube — Yangzhou Fartley Medical Instrument Technology Co., LtdENDOGATOR — MEDIVATORS INC.n.a. — Karl Storz GmbH & Co. KGENDOGATOR — MEDIVATORS INC.ENDOGATOR hybrid irrigation tubing — MEDIVATORS INC.andorate® Air/Water Bottle Tubing — GA Health Company LimitedAndorate — Smartdata Suzhou Co., Ltd.Torrent — US EndoscopyClean Connecting Tube — Yangzhou Fartley Medical Instrument Technology Co., Ltd
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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