This device is classified as import for export, therefore 510k is not applicable.Model vnl11-j10 is available in the usa with a 510k number k172156.We checked the returned unit and confirmed that the insertion flexible tube (ift) spiral closer condition.Based on the result, we concluded that it was caused due to the excessive force applied on the insertion flexible tube (ift).In addition, we confirmed that the u/d lock lever broken, the remote control button perforated, the insertion flexible tube (ift) buckled, the light guide cable for control body buckled, the control body cracked, the light guide cable for prong crushed, and the remote control button leak; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0628(ift)"" and/or the risk analysis results, it was evaluated to submit mdr.
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