XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
FDA 510(k) clearance K030194 · decided 2003-03-24
Clearance details
- K-number
- K030194
- Device name
- XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
- Applicant
- The Olympus Optical Co.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-21
- Decision date
- 2003-03-24
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use recall (Z-1277-2013) | Olympus America Inc. | 2013-05-08 |
| Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA220 recall (Z-0828-2012) | Olympus America Inc. | 2012-01-20 |
| Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22 recall (Z-0829-2012) | Olympus America Inc. | 2012-01-20 |