Model P8400 Hemostatix Thermal Scalpel System

K091107 is the FDA 510(k) clearance record for MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM, a class II device, cleared for Hemostatix Medical Technologies, LLC on 2009-05-01 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 Hemostatix Medical Technologies, LLC, from 2009-05-01 to 2018-11-26. As of 2026-09-10, FDA records show 2 recalls naming K091107.