TANGENT ENDOSCOPY, LLC

FDA Regulatory Profile

TANGENT ENDOSCOPY, LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2209-2026, Class II) was initiated on March 23, 2026. Its most recent 510(k) clearance was granted on September 12, 2025.

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2209-2026Class IITangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNMarch 23, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControlleSeptember 12, 2025