FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SONOSURG SYSTEM
K Number: K032066
·
Decision Oct 3, 2003
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
155
Applicant Total
22
Review Days
92
Basic Information
- Device Name
- SONOSURG SYSTEM
- K Number
- K032066
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THE OLYMPUS OPTICAL CO.
- Date Received
- July 3, 2003
- Decision Date
- October 3, 2003
- Product Code
- LFL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
FDA 510(k)
FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
FDA Unclassified
·Unknown
Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by THE OLYMPUS OPTICAL CO.
| K Number | Device Name | ||
|---|---|---|---|
| K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | Mar 24, 2003 | Substantially Equivalent |
| K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Feb 12, 2003 | Substantially Equivalent |
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES | Jan 31, 2003 | Substantially Equivalent |
| K023272 | DISPOSABLE ASPIRATION NEEDLE NA-200H | Dec 23, 2002 | Substantially Equivalent |
| K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES | Nov 29, 2002 | Substantially Equivalent |
| K012074 | XBO1-824-18/19/20 BIOPSY FORCEPS | Sep 25, 2001 | Substantially Equivalent |
| K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 | Aug 10, 2001 | Substantially Equivalent |
| K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | Jul 25, 2001 | Substantially Equivalent |
| K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | May 15, 2001 | Substantially Equivalent |
| K011149 | DISPOSABLE BENDING CANNULA PR-233Q | May 15, 2001 | Substantially Equivalent |