The following data is part of a premarket notification filed by Microvasive with the FDA for Rigid Fiberopitc Endoscope.
| Device ID | K844769 |
| 510k Number | K844769 |
| Device Name: | RIGID FIBEROPITC ENDOSCOPE |
| Classification | Endoscope, Rigid |
| Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Contact | Alan I West |
| Correspondent | Alan I West MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Product Code | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-07 |
| Decision Date | 1985-01-15 |