Endoscopic Camera Tc804/c4

K014158 is the FDA 510(k) clearance record for ENDOSCOPIC CAMERA TC804/C4, a class II device, cleared for World of Medicine Lemke GmbH on 2002-03-14 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 7 510(k) clearances for World of Medicine Lemke GmbH, from 2002-03-14 to 2003-03-18. As of 2026-09-10, FDA records show one recall naming K014158.