# Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
> **Product code: OTN** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3300
## Classification
- **FDA Product Code:** OTN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.3300
- **Review panel:** GU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

## Market data
- **Cleared 510(k) submissions:** 65
- **Registered establishments:** 28
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OTN)
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