# Penile Implant Surgical Accessories
> **Product code: QGA** · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.3500
## Classification
- **FDA Product Code:** QGA
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 876.3500
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 13
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QGA)
---
*AI Analytics · CC0 1.0*