The following data is part of a premarket notification filed by Suncoast Medical Manufacturers, Inc. with the FDA for Pyro-tip.
| Device ID | K841591 |
| 510k Number | K841591 |
| Device Name: | PYRO-TIP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SUNCOAST MEDICAL MANUFACTURERS, INC. P.O. BOX 3345 Clearwater , FL 33515 - |
| Contact | David L Johns |
| Correspondent | David L Johns SUNCOAST MEDICAL MANUFACTURERS, INC. P.O. BOX 3345 Clearwater , FL 33515 - |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-18 |
| Decision Date | 1984-10-31 |