Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)— 510(k) K231777
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K231777 for Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W), Substantially Equivalent on 2023-08-18. 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 allAdverse 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 →
Recalls naming K231777
K-number listed on FDA's recall record- Z-2338-2025 — Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
- Z-0264-2025 — Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231777.
Data sourced from openFDA. This site is unofficial and independent of the FDA.