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Penile Implant Surgical Accessories

Penile Implant Surgical Accessories 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.

Global Registration Data
Multi-Country Intelligence
Penile Implant Surgical Accessories
Gastroenterology, Urology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QGA

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Class 1

21 CFR 876.3500

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Gastroenterology, Urology

Device Characteristics

No

No

No

Not Eligible

Definition

Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.