The following data is part of a premarket notification filed by Starion Instruments with the FDA for Thermal Cautery Probe.
| Device ID | K050308 |
| 510k Number | K050308 |
| Device Name: | THERMAL CAUTERY PROBE |
| Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
| 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 | HQR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-08 |
| Decision Date | 2005-02-25 |
| Summary: | summary |