The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Electrosurgical Snare Sd-400.
| Device ID | K172734 |
| 510k Number | K172734 |
| Device Name: | Single Use Electrosurgical Snare SD-400 |
| Classification | Snare, Flexible |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-11 |
| Decision Date | 2017-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170396714 | K172734 | 000 |
| 14953170396691 | K172734 | 000 |