Leveen Needle Electrode

K000032 is the FDA 510(k) clearance record for LEVEEN NEEDLE ELECTRODE, a class II device, cleared for Radiotherapeutics Corp. on 2000-03-30 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 Radiotherapeutics Corp., from 1995-02-23 to 2002-07-01. As of 2026-09-10, FDA records show 3 recalls naming K000032.