ViziShot 2 FLEX
Bronchoscope Accessory
Olympus Surgical Technologies America
The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Vizishot 2 Flex.
Pre-market Notification Details
| Device ID | K163469 |
| 510k Number | K163469 |
| Device Name: | ViziShot 2 FLEX |
| Classification | Bronchoscope Accessory |
| Applicant | Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Contact | Mary Anne Patella |
| Correspondent | Mary Anne Patella Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-04-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925043060 | K163469 | 000 |
Trademark Results [ViziShot 2 FLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIZISHOT 2 FLEX 97768646 not registered Live/Pending |
OLYMPUS CORPORATION 2023-01-26 |
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