Filiform And Filiform Follower

Device Code: 1742

Product Code(s): FBW

Device Classification Information

• Device Type ID: 1742
• Device Name: Filiform And Filiform Follower
• Regulation Description: Urethral Dilator.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 876.5520 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FBW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1742
• Device: Filiform And Filiform Follower
• Product Code: FBW
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Urethral Dilator.
• CFR Regulation Number: 876.5520 [🔎]

Device Problems
Incorrect Measurement	7
Use Of Device Problem	1
Difficult To Remove	1
Device Damaged Prior To Use	1
Total Device Problems	10

TPLC Last Update: 2019-04-02 19:58:53