Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps— 510(k) K203277
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K203277 for Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps, Substantially Equivalent on 2021-04-28. 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 →
Recalls naming K203277
K-number listed on FDA's recall record- Z-1640-2026 — Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
- Z-2339-2025 — Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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-2415-2024 — ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
- Z-1167-2024 — ESG PK CUTTING FORCEPS, 5MM, 33CM
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203277.
Data sourced from openFDA. This site is unofficial and independent of the FDA.