Replace-a-Tip Adjustable High Temp.

K841509 is the FDA 510(k) clearance record for REPLACE-A-TIP ADJUSTABLE HIGH TEMP., a class II device, cleared for Suncoast Medical Manufacturers, Inc. on 1984-12-07 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 31 510(k) clearances for Suncoast Medical Manufacturers, Inc., from 1984-01-27 to 1984-12-07. As of 2026-09-10, FDA records show no recalls naming K841509.