FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
K Number: K000095
·
Decision Sep 26, 2000
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
22
Review Days
257
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
- K Number
- K000095
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Olympus Optical Co.
- Date Received
- January 13, 2000
- Decision Date
- September 26, 2000
- 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.
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
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
Other Clearances by The Olympus Optical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K032066 | SONOSURG SYSTEM | Oct 3, 2003 | Substantially Equivalent |
| 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 |
| K011149 | DISPOSABLE BENDING CANNULA PR-233Q | May 15, 2001 | Substantially Equivalent |