OLYMPUS ULTRASONIC SURGICAL SYSTEM— 510(k) K031305
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K031305 for OLYMPUS ULTRASONIC SURGICAL SYSTEM, Substantially Equivalent on 2003-09-23. Applicant: Olympus Optical Co., Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- 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
view allMore clearances from Olympus Optical Co., Ltd.
view all- K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
- K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
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.