← FDA Medical Device Classifications
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
MUK · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4400
Classification
- FDA Product Code
MUK- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4400
- Review panel
- GU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown