Ultrapen Reusable Pencil, Model 130350 Through 130353, Reusable Accessory Electrode Kit (for Use with Ultrapen Pencil),

K001161 is the FDA 510(k) clearance record for ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),, a class II device, cleared for Conmedcorp on 2000-06-07 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 92 510(k) clearances for Conmedcorp, from 1981-03-11 to 2010-11-24. As of 2026-09-10, FDA records show no recalls naming K001161.