Electrosurgical Generator ESG-200— 510(k) K160639
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K160639 for Electrosurgical Generator ESG-200, Substantially Equivalent on 2016-05-04. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- 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
- Hamburg, DE
Recent devices under product code GEI
view allMore clearances from Olympus Winter & Ibe GmbH
view all- K260649 — OES ELITE Cystoscope and Accessories +11 more
- K252043 — Bipolar applicator CelonProBreath (WB990310) +3 more
- K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
- K221522 — HF-cables (resusable)
- K223183 — Light-Guide Cables
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.