The following data is part of a premarket notification filed by Endomedix with the FDA for Endoscope And Accossories.
| Device ID | K926004 |
| 510k Number | K926004 |
| Device Name: | ENDOSCOPE AND ACCOSSORIES |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Contact | Leigh Weintraub |
| Correspondent | Leigh Weintraub ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-27 |
| Decision Date | 1993-02-10 |