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Bright Uro, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253537Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female DeliveryApril 16, 2026
K243052Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female DeliveryMarch 24, 2025