← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS III
QRH — Catheter, Balloon, Urethral, Drug-Coated
Dilate urethral strictures
DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES
Recent clearances
P210020Urotronic, Inc. · pma2025-06-23
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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