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ENDOGATOR Kit
MEDIVATORS INC. · Model 100602 · UDI-DI 00677964059636
OCX
Prescription
1
510(k) clearances
261
Adverse events
18
Recalls
98
Facilities
Description
ENDOGATOR Kit contains the ENDOGATOR Irrigation Tubing for Boston Scientific ENDOSTAT II, Olympus OFP and ENDO STRATUS Irrigation Pumps and the ENDO SMARTCAP Rinse and Insufflation Tubing for certain Olympus GI Endoscopes
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 unintended water fl |
| 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 unintended water fl |
| 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 9/28/2020, expiration |
| 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 9/28/2020, expiration |
| 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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Get your free API keyRead the docsData 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.