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ENDOGATOR Kit

MEDIVATORS INC. · Model 100603 · UDI-DI 00677964059643

OCX Prescription
1
510(k) clearances
261
Adverse events
18
Recalls
98
Facilities

Description

EndoGator Hybrid Tubing Kit for use with Endogator Irrigation Pump, Olympus Pump, gi4000 ESU, and Torrent Irrigation Pump.

Recalls

DateFirmReason
2026-03-31Erbe Medical, LLCDevices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl
2026-03-31Erbe Medical, LLCDevices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl
2022-07-29Hobbs 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 9/28/2020, expiration
2022-07-29Hobbs 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 9/28/2020, expiration
2020-11-03GA HEALTH COMPANY LIMITEDSuction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03GA HEALTH COMPANY LIMITEDSuction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03GA HEALTH COMPANY LIMITEDSuction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03GA HEALTH COMPANY LIMITEDSuction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03GA HEALTH COMPANY LIMITEDSuction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03GA HEALTH COMPANY LIMITEDSuction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.