The following data is part of a premarket notification filed by Pentax Medical with the FDA for Pentax Medical Ed-3490tk, Video Duodenoscope.
| Device ID | K161222 |
| 510k Number | K161222 |
| Device Name: | PENTAX MEDICAL ED-3490TK, Video Duodenoscope |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | PENTAX MEDICAL 3 PARAGON DRIVE Montvale, NJ 07645 |
| Contact | Kanchana Iyer |
| Correspondent | William Goeller PENTAX MEDICAL 3 PARAGON DRIVE Montvale, NJ 07645 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-29 |
| Decision Date | 2018-02-07 |
| Summary: | summary |