Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis

K031133 is the FDA 510(k) clearance record for SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS, a class II device, cleared for Surgrx, Inc. on 2003-07-03 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 12 510(k) clearances for Surgrx, Inc., from 2003-07-03 to 2008-07-28. As of 2026-09-10, FDA records show no recalls naming K031133.