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Evacuator, Gastro-Urology

FDA product code KQT · Class 2 · Gastroenterology, Urology

173
Registered devices
201
Adverse events
12
Recalls
14
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-05-05Olympus Corporation of the AmericasSome sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize
2026-05-05Olympus Corporation of the AmericasSome sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize
2026-05-05Olympus Corporation of the AmericasSome sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize
2026-05-05Olympus Corporation of the AmericasSome sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize
2025-06-18Olympus Corporation of the AmericasDiscrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F
2025-06-18Olympus Corporation of the AmericasDiscrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F
2025-06-18Olympus Corporation of the AmericasDiscrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F
2025-06-18Olympus Corporation of the AmericasDiscrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F
2025-06-18Olympus Corporation of the AmericasDiscrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F
2025-06-18Olympus Corporation of the AmericasDiscrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.