The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Ureteroscope.
| Device ID | K043021 |
| 510k Number | K043021 |
| Device Name: | STRYKER URETEROSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Christopher L Cook |
| Correspondent | Christopher L Cook 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 | 2004-11-03 |
| Decision Date | 2005-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327371253 | K043021 | 000 |