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Laryngoscope, Non-Rigid

FDA product code CAL · Class 1 · Anesthesiology

60
Registered devices
1,099
Adverse events
11
Recalls
8
510(k) clearances

Devices with this code

FNS-2800 — EclerisAincA® — ANESTHESIA ASSOCIATES, INC.n.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGAincA® — ANESTHESIA ASSOCIATES, INC.TOAD™ — Wm & Dg, Inc.NA — Changsha Magill Medical Technology Co., Ltd.DCI — Karl Storz GmbH & Co. KGFIBER INTUBATION SCOPE — PENTAX OF AMERICA, INC.NA — Changsha Magill Medical Technology Co., Ltd.NA — Changsha Magill Medical Technology Co., Ltd.Sensorendo — Sensorendo Medical Technology (Zhuhai) Co., Ltd.AincA® — ANESTHESIA ASSOCIATES, INC.n.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGSensorendo — Sensorendo Medical Technology (Zhuhai) Co., Ltd.Insighter — Shenzhen Insighters Medical Technology Co., Ltd.FIBER INTUBATION SCOPE — PENTAX OF AMERICA, INC.n.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGAincA® — ANESTHESIA ASSOCIATES, INC.n.a. — Karl Storz GmbH & Co. KG

Recent recalls

DateFirmReason
2021-09-10Karl Storz EndoscopyDuring a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk t
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2020-07-27Karl Storz EndoscopyUpdated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used
2016-04-06Pentax Medical CompanyPentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's

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