The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Resprocessed Serfas Energy Probe.
| Device ID | K121855 |
| 510k Number | K121855 |
| Device Name: | RESPROCESSED SERFAS ENERGY PROBE |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST DRAKE DRIVE Tempe, AZ 85283 |
| Contact | Eric Varty |
| Correspondent | Eric Varty STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST DRAKE DRIVE Tempe, AZ 85283 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-25 |
| Decision Date | 2012-08-16 |
| Summary: | summary |