Oratec Interventions Model Tac-S Monopolar Cautery Probe (Modify)

K963157 is the FDA 510(k) clearance record for ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY), a class II device, cleared for Oratec Interventions, Inc. on 1996-09-18 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 24 510(k) clearances for Oratec Interventions, Inc., from 1995-12-18 to 2002-01-31. As of 2026-09-10, FDA records show no recalls naming K963157.