510(k) K020952
- Device
- SURX RF SYSTEM
- Applicant
- SURX, INC.
- 510(k) number
- K020952
- Product code
- MUK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-30
- Date received
- 2002-03-25
- Regulation
- 878.4400
- Classification name
- Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN CURTIS
- Address
- 2675 Collier Canyon Rd. Livermore CA US 94550 94550
Source Documents#
Other 510(k) Records For Product Code MUK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020126 | MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) | Surx, Inc. | 2002-03-15 |
| K011190 | SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) | Surx, Inc. | 2002-01-08 |
Legacy Summary#
summary
FDA Review#
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