The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Xues-41 Endoscopic Electrosurgical Unit.
| Device ID | K030194 |
| 510k Number | K030194 |
| Device Name: | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Donald James Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170287275 | K030194 | 000 |
| 04953170217777 | K030194 | 000 |
| 04953170217753 | K030194 | 000 |
| 04953170165498 | K030194 | 000 |
| 04953170165481 | K030194 | 000 |
| 04953170165429 | K030194 | 000 |