510(k) K042132
- Device
- NOVASYS TRANSURETHRAL RF SYSTEM
- Applicant
- NOVASYS MEDICAL, INC.
- 510(k) number
- K042132
- Product code
- NVJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-21
- Date received
- 2004-08-09
- Regulation
- 878.4400
- Classification name
- Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBRA REISENTHEL
- Address
- 39684 Eureka Dr. Newark CA US 94560 94560
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases