The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip.
| Device ID | K183590 |
| 510k Number | K183590 |
| Device Name: | Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170421348 | K183590 | 000 |
| 04953170200311 | K183590 | 000 |
| 04953170200335 | K183590 | 000 |
| 04953170200359 | K183590 | 000 |
| 04953170200373 | K183590 | 000 |
| 04953170209130 | K183590 | 000 |
| 04953170209154 | K183590 | 000 |
| 14953170390699 | K183590 | 000 |
| 14953170390736 | K183590 | 000 |
| 04953170415111 | K183590 | 000 |
| 04953170415128 | K183590 | 000 |
| 04953170415135 | K183590 | 000 |
| 04953170415142 | K183590 | 000 |
| 04953170415159 | K183590 | 000 |
| 04953170415166 | K183590 | 000 |
| 04953170415173 | K183590 | 000 |
| 14953170421331 | K183590 | 000 |
| 04953170200298 | K183590 | 000 |