FDA product code FHW
Device, Impotence, Mechanical/Hydraulic
Gastroenterology, Urology·Class 3·21 CFR 876.3350·Implantable
US regulatory classifications
- US Product Code (FDA)
- FHWView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 876.3350View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
Device characteristics
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
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About this record
Device, Impotence, Mechanical/Hydraulic is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.