The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Strykeflow Suction Irrigator Gravity Flow.
| Device ID | K963646 |
| 510k Number | K963646 |
| Device Name: | STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Anthony Lee |
| Correspondent | Anthony Lee Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-12 |
| Decision Date | 1997-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327061469 | K963646 | 000 |
| 37613327061353 | K963646 | 000 |
| 07613327051841 | K963646 | 000 |