Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set

K990213 is the FDA 510(k) clearance record for HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET, a class II device, cleared for Gyrus Ent LLC on 1999-02-02 under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)). FDA's definition for product code EOB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 28 510(k) clearances for Gyrus Ent LLC, from 1997-01-22 to 2004-08-20. As of 2026-09-10, FDA records show no recalls naming K990213.