Ndm Diatemp Electrosurgical Dis. Pad

K801158 is the FDA 510(k) clearance record for NDM DIATEMP ELECTROSURGICAL DIS. PAD, a class II device, cleared for Ndm Corp. on 1980-05-23 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 8 510(k) clearances for Ndm Corp., from 1976-08-04 to 1983-04-28. As of 2026-09-10, FDA records show no recalls naming K801158.