Nikkiso Co, Ltd.

CLOSEOUT LETTER Nikkiso Co, Ltd. MARCS-CMS 613109 — July 23, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Koichi Kato Recipient Title Representative Director, President & Chief Executive Officer Nikkiso Co, Ltd. 20-3, Ebisu 4-Chome, Shibuya-ku Tokyo 150-6022 Japan Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Koichi Kato: The Food and Drug Administration has completed an evaluation of Nikkiso’s corrective actions in response to our Warning Letter (CMS #613109; dated May 7th, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Michael J. Hoffmann Director OHT3: Office of GastroRenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Food and Drug Administration Content current as of: 07/29/2025 Regulated Product(s) Medical Devices