The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Crossflow Integrated Arthroscopy Pump.
| Device ID | K191259 |
| 510k Number | K191259 |
| Device Name: | Stryker CrossFlow Integrated Arthroscopy Pump |
| Classification | Arthroscope |
| Applicant | Stryker Corp. 5900 Optical Ct San Jose, CA 95138 |
| Contact | Justin Florence |
| Correspondent | Justin Florence Stryker Corp. 5900 Optical Ct San Jose, CA 95138 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2019-07-12 |