Stellartech 100 Coagulation System

K061544 is the FDA 510(k) clearance record for STELLARTECH 100 COAGULATION SYSTEM, a class II device, cleared for Stellartech Research Corp. on 2006-10-13 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 11 510(k) clearances for Stellartech Research Corp., from 2000-01-20 to 2006-10-13. As of 2026-09-10, FDA records show no recalls naming K061544.