FDA product code FHK
Spreader, Bladder Neck
Gastroenterology, Urology·Class 1·21 CFR 876.4730
US regulatory classifications
- US Product Code (FDA)
- FHKView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 876.4730View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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About this record
Spreader, Bladder Neck 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.
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.