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Urotronic, Inc.

15 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Optilume™ BPH Catheter System (P220029/S003)Urotronic, Inc.2025-12-15
Optilume™ BPH Catheter System (P220029/S004)Urotronic, Inc.2025-12-12
Optilume Urethral Drug Coated Balloon Catheter (P210020/S010)Urotronic, Inc.2025-06-23
Optilume™ BPH Catheter System (P220029/S002)Urotronic, Inc.2024-08-15
Optilume Urethral Drug Coated Balloon catheter (P210020/S009)Urotronic, Inc.2024-01-13
Optilume™ BPH Catheter System (P220029/S001)Urotronic, Inc.2023-08-25
Optilume™ BPH Catheter System (P220029)Urotronic, Inc.2023-06-30
Optilume Urethral Drug Coated Balloon (P210020/S008)Urotronic, Inc.2023-04-25
Optilume Urethral Drug Coated Balloon (P210020/S006)Urotronic, Inc.2022-09-29
Optilume Urethral Drug Coated Balloon (P210020/S005)Urotronic, Inc.2022-06-10
Optilume Urethral Drug Coated Balloon (P210020/S004)Urotronic, Inc.2022-05-17
Optilume Urethral Drug Coated Balloon (P210020/S003)Urotronic, Inc.2022-02-03
Optilume Urethral Drug Coated Balloon (P210020/S002)Urotronic, Inc.2022-01-27
Optilume Urethral Drug Coated Balloon (P210020/S001)Urotronic, Inc.2022-01-19
Optilume Urethral Drug Coated Balloon (P210020)Urotronic, Inc.2021-12-03

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