The following data is part of a premarket notification filed by Medisurg Ltd. with the FDA for The Fugo Blade.
| Device ID | K001498 |
| 510k Number | K001498 |
| Device Name: | THE FUGO BLADE |
| Classification | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered |
| Applicant | MEDISURG LTD. 100 WEST FORNANCE ST. THE FUGO BUILDING Norristown, PA 19401 |
| Contact | Richard J Fugo |
| Correspondent | Richard J Fugo MEDISURG LTD. 100 WEST FORNANCE ST. THE FUGO BUILDING Norristown, PA 19401 |
| Product Code | NCR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-15 |
| Decision Date | 2000-08-10 |