FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVASYS TRANSURETHRAL RF SYSTEM
K Number: K042132
·
Decision Dec 21, 2004
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
134
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Basic Information
- Device Name
- NOVASYS TRANSURETHRAL RF SYSTEM
- K Number
- K042132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Novasys Medical, Inc.
- Date Received
- August 9, 2004
- Decision Date
- December 21, 2004
- Product Code
- NVJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NVJ | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women | FDA class 2 | General, Plastic Surgery |
Other Clearances by Novasys Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013730 | ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES | Feb 6, 2002 | Substantially Equivalent |
| K001328 | INTRODUCER SHEATH | Jul 17, 2000 | Substantially Equivalent |
| K001150 | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE | Jun 29, 2000 | Substantially Equivalent |
| K001151 | ELECTROSURGICAL ELECTRODE FAMILY | Jun 27, 2000 | Substantially Equivalent |