The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Uretero-reno Videoscope Olympus Urf-v3/v3r, Uretero-reno Fiberscope Olympus Urf-p7/p7r.
| Device ID | K181451 |
| 510k Number | K181451 |
| Device Name: | URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| 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 | FGB |
| Subsequent Product Code | FBN |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2019-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170403835 | K181451 | 000 |
| 04953170403811 | K181451 | 000 |
| 04953170403392 | K181451 | 000 |
| 04953170403385 | K181451 | 000 |
| 04953170435133 | K181451 | 000 |
| 04953170435119 | K181451 | 000 |
| 04953170435102 | K181451 | 000 |
| 04953170435096 | K181451 | 000 |