FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K Number: K021962
·
Decision Feb 12, 2003
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
22
Review Days
243
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Basic Information
- Device Name
- OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K Number
- K021962
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Olympus Optical Co.
- Date Received
- June 14, 2002
- Decision Date
- February 12, 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 |
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CUSA® Clarity Ultrasonic Surgical Aspirator System
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Ultrasonic Surgical System
FDA 510(k)
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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 |
| 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 |
| K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | May 15, 2001 | Substantially Equivalent |