The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Neptune E-sep Smoke Evacuation Pencil.
| Device ID | K153679 |
| 510k Number | K153679 |
| Device Name: | Stryker Neptune E-SEP Smoke Evacuation Pencil |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo, MI 49001 |
| Contact | Mairead Twomey |
| Correspondent | Mairead Twomey STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo, MI 49001 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-01-22 |
| Summary: | summary |