The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Electrosurgical Knife Kd-625 , Single Use Electrosurgical Knife Kd-645.
| Device ID | K182408 |
| 510k Number | K182408 |
| Device Name: | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Daphney Germain-kolawole Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170407854 | K182408 | 000 |
| 14953170407847 | K182408 | 000 |
| 14953170407830 | K182408 | 000 |
| 14953170407823 | K182408 | 000 |