Mr. In-Keum Song
President & Chief Executive Officer (CEO)
Insung Medical Co. Ltd.
168 Gieopdosi-Ro
Jijeong-Myeon
Wonju-si
Gangwon-do
26354FEI 3013023209Issued Sep 23, 2025Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013023209.
Violations5
Issue DateSep 23, 2025
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Insung Medical Co. Ltd.
Location
Mr. In-Keum Song
President & Chief Executive Officer (CEO)
Insung Medical Co. Ltd.
168 Gieopdosi-Ro
Jijeong-Myeon
Wonju-si
Gangwon-do
26354
FEI Number
3013023209
Country
South Korea
Issue Date
September 23, 2025
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Insung Medical Co. Ltd. was cited for failing to comply with Medical Device Reporting (MDR) requirements for its ANKOR Endobronchial Tube, a life-supporting medical device. During an FDA inspection in April-May 2025, the company failed to report a device malfunction (carinal cuff inflation failure) within the required 30-calendar-day timeframe after becoming aware of information suggesting the malfunction could cause serious injury or death if it recurred. The company's failure to furnish required MDR information resulted in the device being deemed misbranded under federal law.
Insung Medical Co. Ltd. FDA Warning Letter, September 23, 2025
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