Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula

K962702 is the FDA 510(k) clearance record for SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA, a class II device, cleared for General Surgical Innovations on 1997-02-19 under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ 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 14 510(k) clearances for General Surgical Innovations, from 1993-06-25 to 1999-03-01. As of 2026-09-10, FDA records show no recalls naming K962702.