The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Serfas Energy System.
| Device ID | K041810 |
| 510k Number | K041810 |
| Device Name: | SERFAS ENERGY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Christine Reistetter |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-06 |
| Decision Date | 2004-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327405828 | K041810 | 000 |
| 07613327405811 | K041810 | 000 |