The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch.
| Device ID | K991960 |
| 510k Number | K991960 |
| Device Name: | SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | N. Mani Prakash |
| Correspondent | N. Mani Prakash 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 | 1999-06-10 |
| Decision Date | 1999-08-13 |
| Summary: | summary |