The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Pentax Video Colonoscopes (ec Family).
| Device ID | K131855 |
| 510k Number | K131855 |
| Device Name: | PENTAX VIDEO COLONOSCOPES (EC FAMILY) |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | PENTAX MEDICAL COMPANY 3 PARAGON DRIVE Montvale, NJ 07645 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX MEDICAL COMPANY 3 PARAGON DRIVE Montvale, NJ 07645 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-21 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333243396 | K131855 | 000 |
| 04961333225811 | K131855 | 000 |
| 04961333225040 | K131855 | 000 |
| 04961333224982 | K131855 | 000 |
| 04961333223695 | K131855 | 000 |
| 04961333223060 | K131855 | 000 |
| 04961333222933 | K131855 | 000 |
| 04961333222827 | K131855 | 000 |
| 04961333248186 | K131855 | 000 |
| 04961333248124 | K131855 | 000 |
| 04961333129461 | K131855 | 000 |
| 04961333109685 | K131855 | 000 |
| 04961333226993 | K131855 | 000 |
| 04961333228430 | K131855 | 000 |
| 04961333232383 | K131855 | 000 |
| 04961333232376 | K131855 | 000 |
| 04961333232369 | K131855 | 000 |
| 04961333232352 | K131855 | 000 |
| 04961333232345 | K131855 | 000 |
| 04961333232284 | K131855 | 000 |
| 04961333232277 | K131855 | 000 |
| 04961333232260 | K131855 | 000 |
| 04961333232253 | K131855 | 000 |
| 04961333232239 | K131855 | 000 |
| 04961333228522 | K131855 | 000 |
| 04961333107827 | K131855 | 000 |