The following data is part of a premarket notification filed by Starion Instruments with the FDA for Starion Instruments Thermal Litigating Shears.
| Device ID | K062257 |
| 510k Number | K062257 |
| Device Name: | STARION INSTRUMENTS THERMAL LITIGATING SHEARS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STARION INSTRUMENTS 20665 4TH ST. Saratoga, CA 95070 |
| Contact | Brian Grigsby |
| Correspondent | Brian Grigsby STARION INSTRUMENTS 20665 4TH ST. Saratoga, CA 95070 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-04 |
| Decision Date | 2006-10-10 |
| Summary: | summary |