SONOSURG SYSTEM— 510(k) K032066
Substantially EquivalentThe Olympus Optical Co.
FDA 510(k) clearance K032066 for SONOSURG SYSTEM, Substantially Equivalent on 2003-10-03. Applicant: The Olympus Optical Co.. Device class: Unclassified.
Clearance details
- Applicant
- The Olympus Optical Co.
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code LFL
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More clearances from The Olympus Optical Co.
view all- K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
- K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
- K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H
- K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.