Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
FDA 510(k) clearance K203277 · decided 2021-04-28
Clearance details
- K-number
- K203277
- Device name
- Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
- Applicant
- Olympus Winter & Ibe GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-11-06
- Decision date
- 2021-04-28
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hamburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Ca recall (Z-1640-2026) | Olympus Corporation of the Americas | 2026-03-25 |
| Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-41 recall (Z-2339-2025) | Olympus Corporation of the Americas | 2025-08-19 |
| ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intende recall (Z-2415-2024) | Olympus Corporation of the Americas | 2024-07-23 |
| ESG PK CUTTING FORCEPS, 5MM, 33CM recall (Z-1167-2024) | Olympus Corporation of the Americas | 2024-02-20 |