The following data is part of a premarket notification filed by Springfield Surgical Instruments with the FDA for Insulated Surgical Electrode.
| Device ID | K942499 |
| 510k Number | K942499 |
| Device Name: | INSULATED SURGICAL ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SPRINGFIELD SURGICAL INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
| Contact | Jamy Gannoe |
| Correspondent | Jamy Gannoe SPRINGFIELD SURGICAL INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-24 |
| Decision Date | 1994-07-01 |