The following data is part of a premarket notification filed by Olympus Corporation Of The Americas with the FDA for Visera Cysto-nephro Videoscope Olympus Cyf Type V2, Visera Cysto-nephro Videoscope Olympus Cyf Type Va2, Visera Cysto-ne.
| Device ID | K133538 |
| 510k Number | K133538 |
| Device Name: | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE |
| Classification | Endoscope, Accessories, Narrow Band Spectrum |
| Applicant | OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 |
| Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-18 |
| Decision Date | 2014-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170215544 | K133538 | 000 |
| 04953170215513 | K133538 | 000 |
| 04953170216961 | K133538 | 000 |
| 04953170411212 | K133538 | 000 |
| 04953170411199 | K133538 | 000 |
| 04953170214561 | K133538 | 000 |
| 04953170214516 | K133538 | 000 |
| 04953170214486 | K133538 | 000 |
| 04953170214455 | K133538 | 000 |