The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Video Duodenoscope Ed32-i10.
| Device ID | K202365 |
| 510k Number | K202365 |
| Device Name: | Pentax Medical Video Duodenoscope ED32-i10 |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | Pentax Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | William Goeller |
| Correspondent | William Goeller Pentax Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-19 |
| Decision Date | 2021-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333246236 | K202365 | 000 |
| 04961333246168 | K202365 | 000 |