The following data is part of a premarket notification filed by Pentax Medical with the FDA for Pentax Medical Ed34-i10t, Video Duodenoscope.
| Device ID | K163614 |
| 510k Number | K163614 |
| Device Name: | PENTAX Medical ED34-i10T, Video Duodenoscope |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | PENTAX Medical 3 Paragon Drive Montvale, NJ 07645 |
| Contact | Kanchana Iyer |
| Correspondent | Kanchana Iyer 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 | 2016-12-22 |
| Decision Date | 2017-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333243365 | K163614 | 000 |
| 04961333240142 | K163614 | 000 |
| 04961333232956 | K163614 | 000 |
| 04961333232963 | K163614 | 000 |