The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Strykeflow Electrocautery Probes.
| Device ID | K963765 |
| 510k Number | K963765 |
| Device Name: | STRYKER STRYKEFLOW ELECTROCAUTERY PROBES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Tom Keast |
| Correspondent | Tom Keast 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 | 1996-09-19 |
| Decision Date | 1997-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327051971 | K963765 | 000 |
| 07613327051964 | K963765 | 000 |
| 07613327051957 | K963765 | 000 |
| 07613327051940 | K963765 | 000 |
| 07613327051933 | K963765 | 000 |