510(k) K030194 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
| Applicant | The Olympus Optical Co., Melville NY, US |
| Decision | Substantially Equivalent, Mar 24, 2003 |
| Received | Jan 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2013 | Olympus America Inc. Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")
Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) Terminated |
KNS | None listed |
| Jan 20, 2012 | Olympus America Inc. Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A.
Working element for endoscopic diagnosis and treatment in urological and gynecological applications. Terminated |
KNS | None listed |
| Jan 20, 2012 | Olympus America Inc. Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A.
Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive Terminated |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.