HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE— 510(k) K024138
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K024138 for HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE, Substantially Equivalent on 2003-03-12. Applicant: Olympus Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code GEI
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- K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.