510(k) K020126
K020126 is an FDA 510(k) premarket notification submitted by Surx, Inc. for the device "MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)". The FDA issued a decision of Substantially Equivalent on March 15, 2002. The device falls under product code MUK (Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue), a Class II device regulated under 21 CFR 878.4400. Surx, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2002
- Date Received
- January 15, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- GU
- Submission Type
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence