The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Single Use Electrosurgical Knife Series, Model Kd-610l, Kd-611l, Kd-620lr, Kd-630l, Kf-640l.
| Device ID | K092309 |
| 510k Number | K092309 |
| Device Name: | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-30 |
| Decision Date | 2009-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170325936 | K092309 | 000 |
| 14953170208413 | K092309 | 000 |
| 14953170208420 | K092309 | 000 |
| 14953170208543 | K092309 | 000 |
| 14953170225960 | K092309 | 000 |
| 14953170251501 | K092309 | 000 |
| 14953170251518 | K092309 | 000 |
| 14953170265768 | K092309 | 000 |
| 14953170265775 | K092309 | 000 |
| 14953170265782 | K092309 | 000 |
| 14953170325899 | K092309 | 000 |
| 14953170208406 | K092309 | 000 |