Recipient Title Chief Executive Officer (CEO), Lion Street Medical, d/b/a Pensar Medical LLC, 109 N Post Oak Ln, Suite 525 Houston , TX 77024-7862 United States, (b)(6), (b)(7)(C)Issued Aug 21, 2026Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations8
Issue DateAug 21, 2026
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Lion Street Medical, d/b/a Pensar Medical LLC
Location
Recipient Title Chief Executive Officer (CEO), Lion Street Medical, d/b/a Pensar Medical LLC, 109 N Post Oak Ln, Suite 525 Houston , TX 77024-7862 United States, (b)(6), (b)(7)(C)
FEI Number
N/A
Country
United States
Issue Date
August 21, 2026
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Subject
Medical Device Reporting/Misbranded
Lion Street Medical, d/b/a Pensar Medical LLC FDA Warning Letter, August 21, 2026
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