510(k) K212643 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
POWERSEAL Curved Jaw Sealer and Divider, Double Action
| Applicant | Olympus Surgical Technologies America, Brooklyn Park MN, US |
| Decision | Substantially Equivalent, Sep 27, 2021 |
| Received | Aug 20, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2026 | Olympus Corporation of the Americas POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.
GEI / Electrosurgical, cutting & coagulation & accessories Open, Classified |
GEI | None listed |
| Apr 30, 2024 | Olympus Corporation of the Americas POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy Open, Classified |
GEI | None listed |
| Apr 30, 2024 | Olympus Corporation of the Americas POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy Open, Classified |
GEI | None listed |
| Apr 30, 2024 | Olympus Corporation of the Americas POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy Open, Classified |
GEI | None listed |
| Sep 26, 2022 | Olympus Corporation of the Americas Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures. Open, Classified |
GEI | None listed |
| Sep 26, 2022 | Olympus Corporation of the Americas Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures. Open, Classified |
GEI | None listed |
| Sep 26, 2022 | Olympus Corporation of the Americas Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures. Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.