Erbe Apc Handle and Applicators, Model 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045

K003462 is the FDA 510(k) clearance record for ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045, a class II device, cleared for Erbe USA, Inc. on 2001-01-04 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 39 510(k) clearances for Erbe USA, Inc., from 1994-02-23 to 2022-08-11. As of 2026-09-10, FDA records show no recalls naming K003462.