FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
K Number: K000720
·
Decision May 30, 2000
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
16
Review Days
88
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Basic Information
- Device Name
- SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
- K Number
- K000720
- 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
- Somnus Medical Technologies, Inc.
- Date Received
- March 3, 2000
- Decision Date
- May 30, 2000
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Somnus Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001438 | SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR | May 16, 2000 | Substantially Equivalent |
| K000501 | ELECTROSURGICAL GENERATOR, MODEL S1 | Mar 17, 2000 | Substantially Equivalent |
| K982717 | SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 | Nov 2, 1998 | Substantially Equivalent |
| K973701 | SOMNUS TISSUE COAGULATING ELECTRODE | Jan 30, 1998 | Substantially Equivalent |
| K970837 | SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE | Jan 9, 1998 | Substantially Equivalent |
| K970838 | SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE | Jan 9, 1998 | Substantially Equivalent |
| K973618 | SOMNOPLASTY SYSTEM | Dec 19, 1997 | Substantially Equivalent |
| K971450 | SOMNOPLASTY SYSTEM | Jul 17, 1997 | Substantially Equivalent |
| K971711 | SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR | Jun 24, 1997 | Substantially Equivalent |
| K970809 | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | Jun 18, 1997 | Substantially Equivalent |