FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
K Number: K011190
·
Decision Jan 8, 2002
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
3
Review Days
264
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Basic Information
- Device Name
- SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
- K Number
- K011190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surx, Inc.
- Date Received
- April 19, 2001
- Decision Date
- January 8, 2002
- Product Code
- MUK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MUK | Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUK), ordered by most recent decision date.
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