The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Video Ureteroscope.
| Device ID | K121112 |
| 510k Number | K121112 |
| Device Name: | STRYKER VIDEO URETEROSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Kevin Potgieter, Rac |
| Correspondent | Kevin Potgieter, Rac Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2012-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327060454 | K121112 | 000 |