← FDA Medical Device Classifications
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown