Erbotom Icc 300

K953738 is the FDA 510(k) clearance record for ERBOTOM ICC 300, a class II device, cleared for Erbe Electromedizin GmbH on 1995-10-16 under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 2 510(k) clearances for Erbe Electromedizin GmbH, from 1990-02-13 to 1995-10-16. As of 2026-09-10, FDA records show no recalls naming K953738.