OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device

K221074 is the FDA 510(k) clearance record for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device, a class II device, cleared for Stryker Corporation on 2022-09-16 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 568 510(k) clearances for Stryker Corporation, from 1976-10-05 to 2026-07-30. As of 2026-09-10, FDA records show no recalls naming K221074.